Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial
Identifieur interne : 001340 ( Main/Merge ); précédent : 001339; suivant : 001341Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial
Auteurs : Jun-Yu Shi [République populaire de Chine] ; Ying-Xin Gu [République populaire de Chine] ; Shi-Chong Qiao [République populaire de Chine] ; Long-Fei Zhuang [République populaire de Chine] ; Xiao-Meng Zhang [République populaire de Chine] ; Hong-Chang Lai [République populaire de Chine]Source :
- Trials [ 1745-6215 ] ; 2015.
Descripteurs français
- KwdFr :
- Atrophie, Chine, Conception de prothèse dentaire, Douleur postopératoire (étiologie), Durée opératoire, Enquêtes et questionnaires, Facteurs temps, Humains, Implants dentaires, Maxillaire (), Maxillaire (anatomopathologie), Mâchoire partiellement édentée (), Mâchoire partiellement édentée (diagnostic), Ostéo-intégration, Ostéotomie (), Ostéotomie (effets indésirables), Perte dentaire (), Perte dentaire (diagnostic), Plan de recherche, Protocoles cliniques, Rehaussement du plancher du sinus (), Rehaussement du plancher du sinus (effets indésirables), Résultat thérapeutique, Études prospectives.
- MESH :
- anatomopathologie : Maxillaire.
- diagnostic : Mâchoire partiellement édentée, Perte dentaire.
- effets indésirables : Ostéotomie, Rehaussement du plancher du sinus.
- étiologie : Douleur postopératoire.
- Atrophie, Chine, Conception de prothèse dentaire, Durée opératoire, Enquêtes et questionnaires, Facteurs temps, Humains, Implants dentaires, Maxillaire, Mâchoire partiellement édentée, Ostéo-intégration, Ostéotomie, Perte dentaire, Plan de recherche, Protocoles cliniques, Rehaussement du plancher du sinus, Résultat thérapeutique, Études prospectives.
- Wicri :
- geographic : République populaire de Chine.
English descriptors
- KwdEn :
- Atrophy, China, Clinical Protocols, Dental Implants, Dental Prosthesis Design, Humans, Jaw, Edentulous, Partially (diagnosis), Jaw, Edentulous, Partially (surgery), Maxilla (pathology), Maxilla (surgery), Operative Time, Osseointegration, Osteotomy (adverse effects), Osteotomy (methods), Pain, Postoperative (etiology), Prospective Studies, Research Design, Sinus Floor Augmentation (adverse effects), Sinus Floor Augmentation (methods), Surveys and Questionnaires, Time Factors, Tooth Loss (diagnosis), Tooth Loss (surgery), Treatment Outcome.
- MESH :
- chemical : Dental Implants.
- geographic : China.
- adverse effects : Osteotomy, Sinus Floor Augmentation.
- diagnosis : Jaw, Edentulous, Partially, Tooth Loss.
- etiology : Pain, Postoperative.
- methods : Osteotomy, Sinus Floor Augmentation.
- pathology : Maxilla.
- surgery : Jaw, Edentulous, Partially, Maxilla, Tooth Loss.
- Atrophy, Clinical Protocols, Dental Prosthesis Design, Humans, Operative Time, Osseointegration, Prospective Studies, Research Design, Surveys and Questionnaires, Time Factors, Treatment Outcome.
Abstract
Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional implants. It is assumed that short implants can avoid additional surgical morbidity and are less technically demanding. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of short implants and longer implants combined with osteotome sinus floor elevation (OSFE) technique is limited.
The proposed study is designed as a prospective single-center, three-arm parallel group, randomized controlled trial. We plan to enroll 150 patients in need of dental implant treatment in the posterior maxilla. The inclusion criteria include: age ≧18 years, partial edentulism in the posterior maxilla for at least 3 months from tooth loss, residual bone height ranging from 6 to 8 mm, sufficient bone width (≥6 mm) in the edentulous region. The patients will be divided into three groups according to a table of random numbers: group 1: short implants (6 mm) alone; group 2: short implants (8 mm) combined with osteotome sinus floor elevation (OSFE); group 3: standard implants (10 mm) combined with OSFE. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners and patients will be kept blinded to the assignment. Implant survival rates, implant success rates, complications, resonance frequency analysis (RFA) measurements, marginal bone level, treatment time and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) will be recorded. Clinical re-evaluations will be performed at 12, 24, 36 and 60 months after crown placement.
The results of the trial will support better decision-making for dental implant treatment in atrophic maxillary ridges. If favorable, the use of short implants may avoid adjunct procedures used for implant insertion, thus reducing operative time, complexity and postoperative discomfort.
Clinicaltrials.gov identifier:
Url:
DOI: 10.1186/s13063-015-0853-4
PubMed: 26223254
PubMed Central: 4518682
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PMC:4518682Le document en format XML
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Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Gu, Ying Xin" sort="Gu, Ying Xin" uniqKey="Gu Y" first="Ying-Xin" last="Gu">Ying-Xin Gu</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Oral and Maxillofacial Implantology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Qiao, Shi Chong" sort="Qiao, Shi Chong" uniqKey="Qiao S" first="Shi-Chong" last="Qiao">Shi-Chong Qiao</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Oral and Maxillofacial Implantology, 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wicri:level="1"><nlm:aff id="Aff1">Department of Oral and Maxillofacial Implantology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011 China</nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai</wicri:regionArea><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Atrophy</term><term>China</term><term>Clinical Protocols</term><term>Dental Implants</term><term>Dental Prosthesis Design</term><term>Humans</term><term>Jaw, Edentulous, Partially (diagnosis)</term><term>Jaw, Edentulous, Partially (surgery)</term><term>Maxilla (pathology)</term><term>Maxilla (surgery)</term><term>Operative Time</term><term>Osseointegration</term><term>Osteotomy (adverse effects)</term><term>Osteotomy (methods)</term><term>Pain, Postoperative (etiology)</term><term>Prospective Studies</term><term>Research Design</term><term>Sinus Floor Augmentation (adverse effects)</term><term>Sinus Floor Augmentation (methods)</term><term>Surveys and Questionnaires</term><term>Time Factors</term><term>Tooth Loss (diagnosis)</term><term>Tooth Loss (surgery)</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Atrophie</term><term>Chine</term><term>Conception de prothèse dentaire</term><term>Douleur postopératoire (étiologie)</term><term>Durée opératoire</term><term>Enquêtes et questionnaires</term><term>Facteurs temps</term><term>Humains</term><term>Implants dentaires</term><term>Maxillaire ()</term><term>Maxillaire (anatomopathologie)</term><term>Mâchoire partiellement édentée ()</term><term>Mâchoire partiellement édentée (diagnostic)</term><term>Ostéo-intégration</term><term>Ostéotomie ()</term><term>Ostéotomie (effets indésirables)</term><term>Perte dentaire ()</term><term>Perte dentaire (diagnostic)</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Rehaussement du plancher du sinus ()</term><term>Rehaussement du plancher du sinus (effets indésirables)</term><term>Résultat thérapeutique</term><term>Études prospectives</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Dental Implants</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>China</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Osteotomy</term><term>Sinus Floor Augmentation</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Maxillaire</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Jaw, Edentulous, Partially</term><term>Tooth Loss</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Mâchoire partiellement édentée</term><term>Perte dentaire</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Ostéotomie</term><term>Rehaussement du plancher du sinus</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Pain, Postoperative</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Osteotomy</term><term>Sinus Floor Augmentation</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Maxilla</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Jaw, Edentulous, Partially</term><term>Maxilla</term><term>Tooth Loss</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Douleur postopératoire</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Atrophy</term><term>Clinical Protocols</term><term>Dental Prosthesis Design</term><term>Humans</term><term>Operative Time</term><term>Osseointegration</term><term>Prospective Studies</term><term>Research Design</term><term>Surveys and Questionnaires</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Atrophie</term><term>Chine</term><term>Conception de prothèse dentaire</term><term>Durée opératoire</term><term>Enquêtes et questionnaires</term><term>Facteurs temps</term><term>Humains</term><term>Implants dentaires</term><term>Maxillaire</term><term>Mâchoire partiellement édentée</term><term>Ostéo-intégration</term><term>Ostéotomie</term><term>Perte dentaire</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Rehaussement du plancher du sinus</term><term>Résultat thérapeutique</term><term>Études prospectives</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>République populaire de Chine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional implants. It is assumed that short implants can avoid additional surgical morbidity and are less technically demanding. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of short implants and longer implants combined with osteotome sinus floor elevation (OSFE) technique is limited.</p></sec><sec><title>Methods/Design</title><p>The proposed study is designed as a prospective single-center, three-arm parallel group, randomized controlled trial. We plan to enroll 150 patients in need of dental implant treatment in the posterior maxilla. The inclusion criteria include: age ≧18 years, partial edentulism in the posterior maxilla for at least 3 months from tooth loss, residual bone height ranging from 6 to 8 mm, sufficient bone width (≥6 mm) in the edentulous region. The patients will be divided into three groups according to a table of random numbers: group 1: short implants (6 mm) alone; group 2: short implants (8 mm) combined with osteotome sinus floor elevation (OSFE); group 3: standard implants (10 mm) combined with OSFE. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners and patients will be kept blinded to the assignment. Implant survival rates, implant success rates, complications, resonance frequency analysis (RFA) measurements, marginal bone level, treatment time and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) will be recorded. Clinical re-evaluations will be performed at 12, 24, 36 and 60 months after crown placement.</p></sec><sec><title>Discussion</title><p>The results of the trial will support better decision-making for dental implant treatment in atrophic maxillary ridges. If favorable, the use of short implants may avoid adjunct procedures used for implant insertion, thus reducing operative time, complexity and postoperative discomfort.</p></sec><sec><title>Trial registration</title><p>Clinicaltrials.gov identifier: <ext-link ext-link-type="uri" xlink:href="https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4">NCT02350075</ext-link> (registered on 17 February 2015).</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Jung, Re" uniqKey="Jung R">RE Jung</name></author><author><name sortKey="Pjetursson, Be" uniqKey="Pjetursson B">BE Pjetursson</name></author><author><name sortKey="Glauser, R" uniqKey="Glauser R">R Glauser</name></author><author><name sortKey="Zembic, A" uniqKey="Zembic A">A Zembic</name></author><author><name sortKey="Zwahlen, M" uniqKey="Zwahlen M">M Zwahlen</name></author><author><name sortKey="Lang, Np" uniqKey="Lang N">NP 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uniqKey="Esposito M">M Esposito</name></author><author><name sortKey="Pistilli, R" uniqKey="Pistilli R">R Pistilli</name></author><author><name sortKey="Barausse, C" uniqKey="Barausse C">C Barausse</name></author><author><name sortKey="Felice, P" uniqKey="Felice P">P Felice</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Cochran, Dl" uniqKey="Cochran D">DL Cochran</name></author><author><name sortKey="Buser, D" uniqKey="Buser D">D Buser</name></author><author><name sortKey="Ten Bruggenkate, Cm" uniqKey="Ten Bruggenkate C">CM ten Bruggenkate</name></author><author><name sortKey="Weingart, D" uniqKey="Weingart D">D Weingart</name></author><author><name sortKey="Taylor, Tm" uniqKey="Taylor T">TM Taylor</name></author><author><name sortKey="Bernard, Jp" uniqKey="Bernard J">JP Bernard</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lai, Hc" uniqKey="Lai H">HC Lai</name></author><author><name sortKey="Si, Ms" uniqKey="Si M">MS Si</name></author><author><name sortKey="Zhuang, Lf" uniqKey="Zhuang L">LF Zhuang</name></author><author><name sortKey="Shen, H" uniqKey="Shen H">H Shen</name></author><author><name sortKey="Liu, Yl" uniqKey="Liu Y">YL Liu</name></author><author><name sortKey="Wismeijer, D" uniqKey="Wismeijer D">D Wismeijer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Si, Ms" uniqKey="Si M">MS Si</name></author><author><name sortKey="Mo, Jj" uniqKey="Mo J">JJ Mo</name></author><author><name sortKey="Zhuang, Lf" uniqKey="Zhuang L">LF Zhuang</name></author><author><name sortKey="Gu, Yx" uniqKey="Gu Y">YX Gu</name></author><author><name sortKey="Qiao, Sc" uniqKey="Qiao S">SC Qiao</name></author><author><name sortKey="Lai, Hc" uniqKey="Lai H">HC Lai</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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