Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial
Identifieur interne : 006B55 ( Ncbi/Merge ); précédent : 006B54; suivant : 006B56Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial
Auteurs : Suguru Kimoto [Japon] ; Yasuhiko Kawai [Japon] ; Atsuko Gunji [Japon] ; Hisatomo Kondo [Japon] ; Taro Nomura [Japon] ; Tomohiko Murakami [Japon] ; Akito Tsuboi [Japon] ; Guang Hong [Japon] ; Shunsuke Minakuchi [Japon] ; Yusuke Sato [Japon] ; Gaku Ohwada [Japon] ; Tetsuya Suzuki [Japon] ; Katsuhiko Kimoto [Japon] ; Noriyuki Hoshi [Japon] ; Makiko Saita [Japon] ; Yoshikazu Yoneyama [Japon] ; Yohei Sato [Japon] ; Masakazu Morokuma [Japon] ; Joji Okazaki [Japon] ; Takeshi Maeda [Japon] ; Kenichiro Nakai [Japon] ; Tetsuo Ichikawa [Japon] ; Kan Nagao [Japon] ; Keiko Fujimoto [Japon] ; Hiroshi Murata [Japon] ; Tadafumi Kurogi [Japon] ; Kazuhiro Yoshida [Japon] ; Masahiro Nishimura [Japon] ; Yasuhiro Nishi [Japon] ; Mamoru Murakami [Japon] ; Toshio Hosoi [Japon] ; Taizo Hamada [Japon]Source :
- Trials [ 1745-6215 ] ; 2016.
Abstract
Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application.
This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level.
This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries.
ClinicalTrials.gov
Url:
DOI: 10.1186/s13063-016-1612-x
PubMed: 27756441
PubMed Central: 5070081
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<author><name sortKey="Suzuki, Tetsuya" sort="Suzuki, Tetsuya" uniqKey="Suzuki T" first="Tetsuya" last="Suzuki">Tetsuya Suzuki</name>
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<affiliation><nlm:aff id="Aff7">Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580 Japan</nlm:aff>
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<author><name sortKey="Hoshi, Noriyuki" sort="Hoshi, Noriyuki" uniqKey="Hoshi N" first="Noriyuki" last="Hoshi">Noriyuki Hoshi</name>
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<author><name sortKey="Yoneyama, Yoshikazu" sort="Yoneyama, Yoshikazu" uniqKey="Yoneyama Y" first="Yoshikazu" last="Yoneyama">Yoshikazu Yoneyama</name>
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<affiliation><nlm:aff id="Aff8">Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 230-8501 Japan</wicri:noCountry>
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<author><name sortKey="Sato, Yohei" sort="Sato, Yohei" uniqKey="Sato Y" first="Yohei" last="Sato">Yohei Sato</name>
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<affiliation><nlm:aff id="Aff8">Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</nlm:aff>
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<author><name sortKey="Morokuma, Masakazu" sort="Morokuma, Masakazu" uniqKey="Morokuma M" first="Masakazu" last="Morokuma">Masakazu Morokuma</name>
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<author><name sortKey="Okazaki, Joji" sort="Okazaki, Joji" uniqKey="Okazaki J" first="Joji" last="Okazaki">Joji Okazaki</name>
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<country xml:lang="fr">Japon</country>
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<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka</wicri:regionArea>
<wicri:noRegion>Osaka</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Maeda, Takeshi" sort="Maeda, Takeshi" uniqKey="Maeda T" first="Takeshi" last="Maeda">Takeshi Maeda</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka</wicri:regionArea>
<wicri:noRegion>Osaka</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nakai, Kenichiro" sort="Nakai, Kenichiro" uniqKey="Nakai K" first="Kenichiro" last="Nakai">Kenichiro Nakai</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka</wicri:regionArea>
<wicri:noRegion>Osaka</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ichikawa, Tetsuo" sort="Ichikawa, Tetsuo" uniqKey="Ichikawa T" first="Tetsuo" last="Ichikawa">Tetsuo Ichikawa</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Nagao, Kan" sort="Nagao, Kan" uniqKey="Nagao K" first="Kan" last="Nagao">Kan Nagao</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Fujimoto, Keiko" sort="Fujimoto, Keiko" uniqKey="Fujimoto K" first="Keiko" last="Fujimoto">Keiko Fujimoto</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima</wicri:regionArea>
<wicri:noRegion>Tokushima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Murata, Hiroshi" sort="Murata, Hiroshi" uniqKey="Murata H" first="Hiroshi" last="Murata">Hiroshi Murata</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki</wicri:regionArea>
<wicri:noRegion>Nagasaki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kurogi, Tadafumi" sort="Kurogi, Tadafumi" uniqKey="Kurogi T" first="Tadafumi" last="Kurogi">Tadafumi Kurogi</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki</wicri:regionArea>
<wicri:noRegion>Nagasaki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Yoshida, Kazuhiro" sort="Yoshida, Kazuhiro" uniqKey="Yoshida K" first="Kazuhiro" last="Yoshida">Kazuhiro Yoshida</name>
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<country xml:lang="fr">Japon</country>
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<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki</wicri:regionArea>
<wicri:noRegion>Nagasaki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nishimura, Masahiro" sort="Nishimura, Masahiro" uniqKey="Nishimura M" first="Masahiro" last="Nishimura">Masahiro Nishimura</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff12">Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Nishi, Yasuhiro" sort="Nishi, Yasuhiro" uniqKey="Nishi Y" first="Yasuhiro" last="Nishi">Yasuhiro Nishi</name>
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<country xml:lang="fr">Japon</country>
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</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff12">Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima</wicri:regionArea>
<wicri:noRegion>Kagoshima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Murakami, Mamoru" sort="Murakami, Mamoru" uniqKey="Murakami M" first="Mamoru" last="Murakami">Mamoru Murakami</name>
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<country xml:lang="fr">Japon</country>
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<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff13">Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Hosoi, Toshio" sort="Hosoi, Toshio" uniqKey="Hosoi T" first="Toshio" last="Hosoi">Toshio Hosoi</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
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</affiliation>
<affiliation><nlm:aff id="Aff14">Tsurumi University, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</nlm:aff>
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</affiliation>
</author>
<author><name sortKey="Hamada, Taizo" sort="Hamada, Taizo" uniqKey="Hamada T" first="Taizo" last="Hamada">Taizo Hamada</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff15">Hiroshima University, Kasumi 1-2-3, Minamiku, Hiroshima, 734-8553 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Hiroshima University, Kasumi 1-2-3, Minamiku, Hiroshima</wicri:regionArea>
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</affiliation>
</author>
</titleStmt>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial</title>
<author><name sortKey="Kimoto, Suguru" sort="Kimoto, Suguru" uniqKey="Kimoto S" first="Suguru" last="Kimoto">Suguru Kimoto</name>
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<country xml:lang="fr">Japon</country>
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<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff2">Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587 Japan</nlm:aff>
<wicri:noCountry code="subfield">Chiba 271-8587 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Kawai, Yasuhiko" sort="Kawai, Yasuhiko" uniqKey="Kawai Y" first="Yasuhiko" last="Kawai">Yasuhiko Kawai</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff2">Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587 Japan</nlm:aff>
<wicri:noCountry code="subfield">Chiba 271-8587 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Gunji, Atsuko" sort="Gunji, Atsuko" uniqKey="Gunji A" first="Atsuko" last="Gunji">Atsuko Gunji</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff2">Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587 Japan</nlm:aff>
<wicri:noCountry code="subfield">Chiba 271-8587 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Kondo, Hisatomo" sort="Kondo, Hisatomo" uniqKey="Kondo H" first="Hisatomo" last="Kondo">Hisatomo Kondo</name>
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<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="Aff3">Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka</wicri:regionArea>
<orgName type="university">Université de médecine d'Iwate</orgName>
<placeName><settlement type="city">Morioka</settlement>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Nomura, Taro" sort="Nomura, Taro" uniqKey="Nomura T" first="Taro" last="Nomura">Taro Nomura</name>
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<country xml:lang="fr">Japon</country>
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<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="Aff3">Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka</wicri:regionArea>
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<placeName><settlement type="city">Morioka</settlement>
<region type="prefecture">Préfecture d'Iwate</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Murakami, Tomohiko" sort="Murakami, Tomohiko" uniqKey="Murakami T" first="Tomohiko" last="Murakami">Tomohiko Murakami</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="Aff3">Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka</wicri:regionArea>
<orgName type="university">Université de médecine d'Iwate</orgName>
<placeName><settlement type="city">Morioka</settlement>
<region type="prefecture">Préfecture d'Iwate</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tsuboi, Akito" sort="Tsuboi, Akito" uniqKey="Tsuboi A" first="Akito" last="Tsuboi">Akito Tsuboi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="Aff4">Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai</wicri:regionArea>
<orgName type="university">Université du Tōhoku</orgName>
<placeName><settlement type="city">Sendai</settlement>
<region type="province">Région de Tōhoku</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hong, Guang" sort="Hong, Guang" uniqKey="Hong G" first="Guang" last="Hong">Guang Hong</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="Aff4">Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai</wicri:regionArea>
<orgName type="university">Université du Tōhoku</orgName>
<placeName><settlement type="city">Sendai</settlement>
<region type="province">Région de Tōhoku</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Minakuchi, Shunsuke" sort="Minakuchi, Shunsuke" uniqKey="Minakuchi S" first="Shunsuke" last="Minakuchi">Shunsuke Minakuchi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="Aff5">Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo</wicri:regionArea>
<placeName><settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sato, Yusuke" sort="Sato, Yusuke" uniqKey="Sato Y" first="Yusuke" last="Sato">Yusuke Sato</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="Aff5">Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo</wicri:regionArea>
<placeName><settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ohwada, Gaku" sort="Ohwada, Gaku" uniqKey="Ohwada G" first="Gaku" last="Ohwada">Gaku Ohwada</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="Aff5">Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo</wicri:regionArea>
<placeName><settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Suzuki, Tetsuya" sort="Suzuki, Tetsuya" uniqKey="Suzuki T" first="Tetsuya" last="Suzuki">Tetsuya Suzuki</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="Aff6">Section of Oral Prosthetic Engineering, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Section of Oral Prosthetic Engineering, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo</wicri:regionArea>
<placeName><settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kimoto, Katsuhiko" sort="Kimoto, Katsuhiko" uniqKey="Kimoto K" first="Katsuhiko" last="Kimoto">Katsuhiko Kimoto</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff7">Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 238-8580 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Hoshi, Noriyuki" sort="Hoshi, Noriyuki" uniqKey="Hoshi N" first="Noriyuki" last="Hoshi">Noriyuki Hoshi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff7">Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 238-8580 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Saita, Makiko" sort="Saita, Makiko" uniqKey="Saita M" first="Makiko" last="Saita">Makiko Saita</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff7">Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 238-8580 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Yoneyama, Yoshikazu" sort="Yoneyama, Yoshikazu" uniqKey="Yoneyama Y" first="Yoshikazu" last="Yoneyama">Yoshikazu Yoneyama</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff8">Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 230-8501 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Sato, Yohei" sort="Sato, Yohei" uniqKey="Sato Y" first="Yohei" last="Sato">Yohei Sato</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff8">Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 230-8501 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Morokuma, Masakazu" sort="Morokuma, Masakazu" uniqKey="Morokuma M" first="Masakazu" last="Morokuma">Masakazu Morokuma</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Okazaki, Joji" sort="Okazaki, Joji" uniqKey="Okazaki J" first="Joji" last="Okazaki">Joji Okazaki</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka</wicri:regionArea>
<wicri:noRegion>Osaka</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Maeda, Takeshi" sort="Maeda, Takeshi" uniqKey="Maeda T" first="Takeshi" last="Maeda">Takeshi Maeda</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka</wicri:regionArea>
<wicri:noRegion>Osaka</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nakai, Kenichiro" sort="Nakai, Kenichiro" uniqKey="Nakai K" first="Kenichiro" last="Nakai">Kenichiro Nakai</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka</wicri:regionArea>
<wicri:noRegion>Osaka</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ichikawa, Tetsuo" sort="Ichikawa, Tetsuo" uniqKey="Ichikawa T" first="Tetsuo" last="Ichikawa">Tetsuo Ichikawa</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima</wicri:regionArea>
<wicri:noRegion>Tokushima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nagao, Kan" sort="Nagao, Kan" uniqKey="Nagao K" first="Kan" last="Nagao">Kan Nagao</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima</wicri:regionArea>
<wicri:noRegion>Tokushima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Fujimoto, Keiko" sort="Fujimoto, Keiko" uniqKey="Fujimoto K" first="Keiko" last="Fujimoto">Keiko Fujimoto</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima</wicri:regionArea>
<wicri:noRegion>Tokushima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Murata, Hiroshi" sort="Murata, Hiroshi" uniqKey="Murata H" first="Hiroshi" last="Murata">Hiroshi Murata</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki</wicri:regionArea>
<wicri:noRegion>Nagasaki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kurogi, Tadafumi" sort="Kurogi, Tadafumi" uniqKey="Kurogi T" first="Tadafumi" last="Kurogi">Tadafumi Kurogi</name>
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<country xml:lang="fr">Japon</country>
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<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki</wicri:regionArea>
<wicri:noRegion>Nagasaki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Yoshida, Kazuhiro" sort="Yoshida, Kazuhiro" uniqKey="Yoshida K" first="Kazuhiro" last="Yoshida">Kazuhiro Yoshida</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki</wicri:regionArea>
<wicri:noRegion>Nagasaki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nishimura, Masahiro" sort="Nishimura, Masahiro" uniqKey="Nishimura M" first="Masahiro" last="Nishimura">Masahiro Nishimura</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff12">Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima</wicri:regionArea>
<wicri:noRegion>Kagoshima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Nishi, Yasuhiro" sort="Nishi, Yasuhiro" uniqKey="Nishi Y" first="Yasuhiro" last="Nishi">Yasuhiro Nishi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff12">Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima</wicri:regionArea>
<wicri:noRegion>Kagoshima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Murakami, Mamoru" sort="Murakami, Mamoru" uniqKey="Murakami M" first="Mamoru" last="Murakami">Mamoru Murakami</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff13">Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima</wicri:regionArea>
<wicri:noRegion>Kagoshima</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hosoi, Toshio" sort="Hosoi, Toshio" uniqKey="Hosoi T" first="Toshio" last="Hosoi">Toshio Hosoi</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation><nlm:aff id="Aff14">Tsurumi University, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</nlm:aff>
<wicri:noCountry code="subfield">Kanagawa 230-8501 Japan</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Hamada, Taizo" sort="Hamada, Taizo" uniqKey="Hamada T" first="Taizo" last="Hamada">Taizo Hamada</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa</wicri:regionArea>
<wicri:noRegion>Kanagawa</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff15">Hiroshima University, Kasumi 1-2-3, Minamiku, Hiroshima, 734-8553 Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Hiroshima University, Kasumi 1-2-3, Minamiku, Hiroshima</wicri:regionArea>
<wicri:noRegion>Hiroshima</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application.</p>
</sec>
<sec><title>Methods</title>
<p>This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level.</p>
</sec>
<sec><title>Discussion</title>
<p>This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries.</p>
</sec>
<sec><title>Trial registration</title>
<p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01712802?term=DAG&rank=4">NCT01712802</ext-link>
. Registered on 17 October 2012.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id>
<journal-id journal-id-type="iso-abbrev">Trials</journal-id>
<journal-title-group><journal-title>Trials</journal-title>
</journal-title-group>
<issn pub-type="epub">1745-6215</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27756441</article-id>
<article-id pub-id-type="pmc">5070081</article-id>
<article-id pub-id-type="publisher-id">1612</article-id>
<article-id pub-id-type="doi">10.1186/s13063-016-1612-x</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject>
</subj-group>
</article-categories>
<title-group><article-title>Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0001-5050-5742</contrib-id>
<name><surname>Kimoto</surname>
<given-names>Suguru</given-names>
</name>
<address><email>kimoto.suguru@nihon-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kawai</surname>
<given-names>Yasuhiko</given-names>
</name>
<address><email>kawai.yasuhiko@nihon-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gunji</surname>
<given-names>Atsuko</given-names>
</name>
<address><email>gunji.atsuko@nihon-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kondo</surname>
<given-names>Hisatomo</given-names>
</name>
<address><email>hkondo@iwate-med.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nomura</surname>
<given-names>Taro</given-names>
</name>
<address><email>tanomura@iwate-med.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Murakami</surname>
<given-names>Tomohiko</given-names>
</name>
<address><email>imu.44th.murakami@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Tsuboi</surname>
<given-names>Akito</given-names>
</name>
<address><email>tsuboi@m.tohoku.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hong</surname>
<given-names>Guang</given-names>
</name>
<address><email>hong@m.tohoku.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Minakuchi</surname>
<given-names>Shunsuke</given-names>
</name>
<address><email>s.minakuchi.gerd@tmd.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Sato</surname>
<given-names>Yusuke</given-names>
</name>
<address><email>y.sato.gerd@tmd.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ohwada</surname>
<given-names>Gaku</given-names>
</name>
<address><email>g.ohwada.gerd@tmd.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Suzuki</surname>
<given-names>Tetsuya</given-names>
</name>
<address><email>suzuki.peoe@tmd.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kimoto</surname>
<given-names>Katsuhiko</given-names>
</name>
<address><email>k.kimoto@kdu.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hoshi</surname>
<given-names>Noriyuki</given-names>
</name>
<address><email>hoshi@kdu.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Saita</surname>
<given-names>Makiko</given-names>
</name>
<address><email>saita@kdu.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yoneyama</surname>
<given-names>Yoshikazu</given-names>
</name>
<address><email>yoneyama-y@tsurumi-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Sato</surname>
<given-names>Yohei</given-names>
</name>
<address><email>sato-yohei@tsurumi-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Morokuma</surname>
<given-names>Masakazu</given-names>
</name>
<address><email>info@morokumashika.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Okazaki</surname>
<given-names>Joji</given-names>
</name>
<address><email>joji@cc.osaka-dent.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff9">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Maeda</surname>
<given-names>Takeshi</given-names>
</name>
<address><email>maeda-t@cc.osaka-dent.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff9">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nakai</surname>
<given-names>Kenichiro</given-names>
</name>
<address><email>nakai-ks@cc.osaka-dent.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff9">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ichikawa</surname>
<given-names>Tetsuo</given-names>
</name>
<address><email>ichi@tokushima-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nagao</surname>
<given-names>Kan</given-names>
</name>
<address><email>kan@tokushima-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fujimoto</surname>
<given-names>Keiko</given-names>
</name>
<address><email>c301451014@tokushima-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Murata</surname>
<given-names>Hiroshi</given-names>
</name>
<address><email>hmurata@nagasaki-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kurogi</surname>
<given-names>Tadafumi</given-names>
</name>
<address><email>kurofumi@nagasaki-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yoshida</surname>
<given-names>Kazuhiro</given-names>
</name>
<address><email>kyoshida@nagasaki-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nishimura</surname>
<given-names>Masahiro</given-names>
</name>
<address><email>mnishi@dent.kagoshima-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff12">12</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nishi</surname>
<given-names>Yasuhiro</given-names>
</name>
<address><email>shar@dent.kagoshima-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff12">12</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Murakami</surname>
<given-names>Mamoru</given-names>
</name>
<address><email>kaku@dent.kagoshima-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff13">13</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hosoi</surname>
<given-names>Toshio</given-names>
</name>
<address><email>hosoi-t@tsurumi-u.ac.jp</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff14">14</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hamada</surname>
<given-names>Taizo</given-names>
</name>
<address><email>thamada66@gmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
<xref ref-type="aff" rid="Aff15">15</xref>
</contrib>
<aff id="Aff1"><label>1</label>
The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501 Japan</aff>
<aff id="Aff2"><label>2</label>
Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587 Japan</aff>
<aff id="Aff3"><label>3</label>
Department of Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505 Japan</aff>
<aff id="Aff4"><label>4</label>
Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573 Japan</aff>
<aff id="Aff5"><label>5</label>
Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549 Japan</aff>
<aff id="Aff6"><label>6</label>
Section of Oral Prosthetic Engineering, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549 Japan</aff>
<aff id="Aff7"><label>7</label>
Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa 238-8580 Japan</aff>
<aff id="Aff8"><label>8</label>
Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</aff>
<aff id="Aff9"><label>9</label>
Department of Removable Prosthodontics, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008 Japan</aff>
<aff id="Aff10"><label>10</label>
Department of Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504 Japan</aff>
<aff id="Aff11"><label>11</label>
Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588 Japan</aff>
<aff id="Aff12"><label>12</label>
Department of Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</aff>
<aff id="Aff13"><label>13</label>
Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima, 890-8544 Japan</aff>
<aff id="Aff14"><label>14</label>
Tsurumi University, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa 230-8501 Japan</aff>
<aff id="Aff15"><label>15</label>
Hiroshima University, Kasumi 1-2-3, Minamiku, Hiroshima, 734-8553 Japan</aff>
</contrib-group>
<pub-date pub-type="epub"><day>18</day>
<month>10</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>18</day>
<month>10</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="collection"><year>2016</year>
</pub-date>
<volume>17</volume>
<elocation-id>506</elocation-id>
<history><date date-type="received"><day>17</day>
<month>5</month>
<year>2016</year>
</date>
<date date-type="accepted"><day>20</day>
<month>9</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s). 2016</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application.</p>
</sec>
<sec><title>Methods</title>
<p>This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level.</p>
</sec>
<sec><title>Discussion</title>
<p>This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries.</p>
</sec>
<sec><title>Trial registration</title>
<p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01712802?term=DAG&rank=4">NCT01712802</ext-link>
. Registered on 17 October 2012.</p>
</sec>
</abstract>
<kwd-group xml:lang="en"><title>Keywords</title>
<kwd>Complete denture</kwd>
<kwd>Edentulism</kwd>
<kwd>Denture adhesive</kwd>
<kwd>Retentive force</kwd>
<kwd>Occlusal bite force</kwd>
<kwd>Masticatory performance</kwd>
<kwd>Oral health-related quality of life</kwd>
</kwd-group>
<funding-group><award-group><funding-source><institution>Grant-in-Aid for Scientific Research</institution>
</funding-source>
<award-id>24390439</award-id>
<principal-award-recipient><name><surname>Kawai</surname>
<given-names>Yasuhiko</given-names>
</name>
</principal-award-recipient>
</award-group>
</funding-group>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2016</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Japon</li>
</country>
<region><li>Préfecture d'Iwate</li>
<li>Région de Kantō</li>
<li>Région de Tōhoku</li>
</region>
<settlement><li>Morioka</li>
<li>Sendai</li>
<li>Tokyo</li>
</settlement>
<orgName><li>Université de médecine d'Iwate</li>
<li>Université du Tōhoku</li>
</orgName>
</list>
<tree><country name="Japon"><noRegion><name sortKey="Kimoto, Suguru" sort="Kimoto, Suguru" uniqKey="Kimoto S" first="Suguru" last="Kimoto">Suguru Kimoto</name>
</noRegion>
<name sortKey="Fujimoto, Keiko" sort="Fujimoto, Keiko" uniqKey="Fujimoto K" first="Keiko" last="Fujimoto">Keiko Fujimoto</name>
<name sortKey="Fujimoto, Keiko" sort="Fujimoto, Keiko" uniqKey="Fujimoto K" first="Keiko" last="Fujimoto">Keiko Fujimoto</name>
<name sortKey="Gunji, Atsuko" sort="Gunji, Atsuko" uniqKey="Gunji A" first="Atsuko" last="Gunji">Atsuko Gunji</name>
<name sortKey="Hamada, Taizo" sort="Hamada, Taizo" uniqKey="Hamada T" first="Taizo" last="Hamada">Taizo Hamada</name>
<name sortKey="Hamada, Taizo" sort="Hamada, Taizo" uniqKey="Hamada T" first="Taizo" last="Hamada">Taizo Hamada</name>
<name sortKey="Hong, Guang" sort="Hong, Guang" uniqKey="Hong G" first="Guang" last="Hong">Guang Hong</name>
<name sortKey="Hong, Guang" sort="Hong, Guang" uniqKey="Hong G" first="Guang" last="Hong">Guang Hong</name>
<name sortKey="Hoshi, Noriyuki" sort="Hoshi, Noriyuki" uniqKey="Hoshi N" first="Noriyuki" last="Hoshi">Noriyuki Hoshi</name>
<name sortKey="Hosoi, Toshio" sort="Hosoi, Toshio" uniqKey="Hosoi T" first="Toshio" last="Hosoi">Toshio Hosoi</name>
<name sortKey="Ichikawa, Tetsuo" sort="Ichikawa, Tetsuo" uniqKey="Ichikawa T" first="Tetsuo" last="Ichikawa">Tetsuo Ichikawa</name>
<name sortKey="Ichikawa, Tetsuo" sort="Ichikawa, Tetsuo" uniqKey="Ichikawa T" first="Tetsuo" last="Ichikawa">Tetsuo Ichikawa</name>
<name sortKey="Kawai, Yasuhiko" sort="Kawai, Yasuhiko" uniqKey="Kawai Y" first="Yasuhiko" last="Kawai">Yasuhiko Kawai</name>
<name sortKey="Kimoto, Katsuhiko" sort="Kimoto, Katsuhiko" uniqKey="Kimoto K" first="Katsuhiko" last="Kimoto">Katsuhiko Kimoto</name>
<name sortKey="Kondo, Hisatomo" sort="Kondo, Hisatomo" uniqKey="Kondo H" first="Hisatomo" last="Kondo">Hisatomo Kondo</name>
<name sortKey="Kondo, Hisatomo" sort="Kondo, Hisatomo" uniqKey="Kondo H" first="Hisatomo" last="Kondo">Hisatomo Kondo</name>
<name sortKey="Kurogi, Tadafumi" sort="Kurogi, Tadafumi" uniqKey="Kurogi T" first="Tadafumi" last="Kurogi">Tadafumi Kurogi</name>
<name sortKey="Kurogi, Tadafumi" sort="Kurogi, Tadafumi" uniqKey="Kurogi T" first="Tadafumi" last="Kurogi">Tadafumi Kurogi</name>
<name sortKey="Maeda, Takeshi" sort="Maeda, Takeshi" uniqKey="Maeda T" first="Takeshi" last="Maeda">Takeshi Maeda</name>
<name sortKey="Maeda, Takeshi" sort="Maeda, Takeshi" uniqKey="Maeda T" first="Takeshi" last="Maeda">Takeshi Maeda</name>
<name sortKey="Minakuchi, Shunsuke" sort="Minakuchi, Shunsuke" uniqKey="Minakuchi S" first="Shunsuke" last="Minakuchi">Shunsuke Minakuchi</name>
<name sortKey="Minakuchi, Shunsuke" sort="Minakuchi, Shunsuke" uniqKey="Minakuchi S" first="Shunsuke" last="Minakuchi">Shunsuke Minakuchi</name>
<name sortKey="Morokuma, Masakazu" sort="Morokuma, Masakazu" uniqKey="Morokuma M" first="Masakazu" last="Morokuma">Masakazu Morokuma</name>
<name sortKey="Murakami, Mamoru" sort="Murakami, Mamoru" uniqKey="Murakami M" first="Mamoru" last="Murakami">Mamoru Murakami</name>
<name sortKey="Murakami, Mamoru" sort="Murakami, Mamoru" uniqKey="Murakami M" first="Mamoru" last="Murakami">Mamoru Murakami</name>
<name sortKey="Murakami, Tomohiko" sort="Murakami, Tomohiko" uniqKey="Murakami T" first="Tomohiko" last="Murakami">Tomohiko Murakami</name>
<name sortKey="Murakami, Tomohiko" sort="Murakami, Tomohiko" uniqKey="Murakami T" first="Tomohiko" last="Murakami">Tomohiko Murakami</name>
<name sortKey="Murata, Hiroshi" sort="Murata, Hiroshi" uniqKey="Murata H" first="Hiroshi" last="Murata">Hiroshi Murata</name>
<name sortKey="Murata, Hiroshi" sort="Murata, Hiroshi" uniqKey="Murata H" first="Hiroshi" last="Murata">Hiroshi Murata</name>
<name sortKey="Nagao, Kan" sort="Nagao, Kan" uniqKey="Nagao K" first="Kan" last="Nagao">Kan Nagao</name>
<name sortKey="Nagao, Kan" sort="Nagao, Kan" uniqKey="Nagao K" first="Kan" last="Nagao">Kan Nagao</name>
<name sortKey="Nakai, Kenichiro" sort="Nakai, Kenichiro" uniqKey="Nakai K" first="Kenichiro" last="Nakai">Kenichiro Nakai</name>
<name sortKey="Nakai, Kenichiro" sort="Nakai, Kenichiro" uniqKey="Nakai K" first="Kenichiro" last="Nakai">Kenichiro Nakai</name>
<name sortKey="Nishi, Yasuhiro" sort="Nishi, Yasuhiro" uniqKey="Nishi Y" first="Yasuhiro" last="Nishi">Yasuhiro Nishi</name>
<name sortKey="Nishi, Yasuhiro" sort="Nishi, Yasuhiro" uniqKey="Nishi Y" first="Yasuhiro" last="Nishi">Yasuhiro Nishi</name>
<name sortKey="Nishimura, Masahiro" sort="Nishimura, Masahiro" uniqKey="Nishimura M" first="Masahiro" last="Nishimura">Masahiro Nishimura</name>
<name sortKey="Nishimura, Masahiro" sort="Nishimura, Masahiro" uniqKey="Nishimura M" first="Masahiro" last="Nishimura">Masahiro Nishimura</name>
<name sortKey="Nomura, Taro" sort="Nomura, Taro" uniqKey="Nomura T" first="Taro" last="Nomura">Taro Nomura</name>
<name sortKey="Nomura, Taro" sort="Nomura, Taro" uniqKey="Nomura T" first="Taro" last="Nomura">Taro Nomura</name>
<name sortKey="Ohwada, Gaku" sort="Ohwada, Gaku" uniqKey="Ohwada G" first="Gaku" last="Ohwada">Gaku Ohwada</name>
<name sortKey="Ohwada, Gaku" sort="Ohwada, Gaku" uniqKey="Ohwada G" first="Gaku" last="Ohwada">Gaku Ohwada</name>
<name sortKey="Okazaki, Joji" sort="Okazaki, Joji" uniqKey="Okazaki J" first="Joji" last="Okazaki">Joji Okazaki</name>
<name sortKey="Okazaki, Joji" sort="Okazaki, Joji" uniqKey="Okazaki J" first="Joji" last="Okazaki">Joji Okazaki</name>
<name sortKey="Saita, Makiko" sort="Saita, Makiko" uniqKey="Saita M" first="Makiko" last="Saita">Makiko Saita</name>
<name sortKey="Sato, Yohei" sort="Sato, Yohei" uniqKey="Sato Y" first="Yohei" last="Sato">Yohei Sato</name>
<name sortKey="Sato, Yusuke" sort="Sato, Yusuke" uniqKey="Sato Y" first="Yusuke" last="Sato">Yusuke Sato</name>
<name sortKey="Sato, Yusuke" sort="Sato, Yusuke" uniqKey="Sato Y" first="Yusuke" last="Sato">Yusuke Sato</name>
<name sortKey="Suzuki, Tetsuya" sort="Suzuki, Tetsuya" uniqKey="Suzuki T" first="Tetsuya" last="Suzuki">Tetsuya Suzuki</name>
<name sortKey="Suzuki, Tetsuya" sort="Suzuki, Tetsuya" uniqKey="Suzuki T" first="Tetsuya" last="Suzuki">Tetsuya Suzuki</name>
<name sortKey="Tsuboi, Akito" sort="Tsuboi, Akito" uniqKey="Tsuboi A" first="Akito" last="Tsuboi">Akito Tsuboi</name>
<name sortKey="Tsuboi, Akito" sort="Tsuboi, Akito" uniqKey="Tsuboi A" first="Akito" last="Tsuboi">Akito Tsuboi</name>
<name sortKey="Yoneyama, Yoshikazu" sort="Yoneyama, Yoshikazu" uniqKey="Yoneyama Y" first="Yoshikazu" last="Yoneyama">Yoshikazu Yoneyama</name>
<name sortKey="Yoshida, Kazuhiro" sort="Yoshida, Kazuhiro" uniqKey="Yoshida K" first="Kazuhiro" last="Yoshida">Kazuhiro Yoshida</name>
<name sortKey="Yoshida, Kazuhiro" sort="Yoshida, Kazuhiro" uniqKey="Yoshida K" first="Kazuhiro" last="Yoshida">Kazuhiro Yoshida</name>
</country>
</tree>
</affiliations>
</record>
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