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 : 000388 ( PubMed/Corpus ); précédent : 000387; suivant : 000389Clinical 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 ; Ying-Xin Gu ; Shi-Chong Qiao ; Long-Fei Zhuang ; Xiao-Meng Zhang ; Hong-Chang LaiSource :
- Trials [ 1745-6215 ] ; 2015.
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.
DOI: 10.1186/s13063-015-0853-4
PubMed: 26223254
Links to Exploration step
pubmed:26223254Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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.</title><author><name sortKey="Shi, Jun Yu" sort="Shi, Jun Yu" uniqKey="Shi J" first="Jun-Yu" last="Shi">Jun-Yu Shi</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. sakyamuni_jin@163.com.</nlm:affiliation></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><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. yingxingu@163.com.</nlm:affiliation></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><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. shichong-qiao@hotmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Zhuang, Long Fei" sort="Zhuang, Long Fei" uniqKey="Zhuang L" first="Long-Fei" last="Zhuang">Long-Fei Zhuang</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. longfei_82@hotmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Xiao Meng" sort="Zhang, Xiao Meng" uniqKey="Zhang X" first="Xiao-Meng" last="Zhang">Xiao-Meng Zhang</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. zhangxiaomengwowo@126.com.</nlm:affiliation></affiliation></author><author><name sortKey="Lai, Hong Chang" sort="Lai, Hong Chang" uniqKey="Lai H" first="Hong-Chang" last="Lai">Hong-Chang Lai</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. lhc9@hotmail.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26223254</idno><idno type="pmid">26223254</idno><idno type="doi">10.1186/s13063-015-0853-4</idno><idno type="wicri:Area/PubMed/Corpus">000388</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000388</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><author><name sortKey="Shi, Jun Yu" sort="Shi, Jun Yu" uniqKey="Shi J" first="Jun-Yu" last="Shi">Jun-Yu Shi</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. sakyamuni_jin@163.com.</nlm:affiliation></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><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. yingxingu@163.com.</nlm:affiliation></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><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. shichong-qiao@hotmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Zhuang, Long Fei" sort="Zhuang, Long Fei" uniqKey="Zhuang L" first="Long-Fei" last="Zhuang">Long-Fei Zhuang</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. longfei_82@hotmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Xiao Meng" sort="Zhang, Xiao Meng" uniqKey="Zhang X" first="Xiao-Meng" last="Zhang">Xiao-Meng Zhang</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. zhangxiaomengwowo@126.com.</nlm:affiliation></affiliation></author><author><name sortKey="Lai, Hong Chang" sort="Lai, Hong Chang" uniqKey="Lai H" first="Hong-Chang" last="Lai">Hong-Chang Lai</name><affiliation><nlm:affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. lhc9@hotmail.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015" type="published">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="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="diagnosis" xml:lang="en"><term>Jaw, Edentulous, Partially</term><term>Tooth Loss</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" 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></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26223254</PMID><DateCompleted><Year>2016</Year><Month>06</Month><Day>03</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><PubDate><Year>2015</Year><Month>Jul</Month><Day>30</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><MedlinePgn>324</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-015-0853-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">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.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">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.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">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.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Clinicaltrials.gov identifier: NCT02350075 (registered on 17 February 2015).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Shi</LastName><ForeName>Jun-Yu</ForeName><Initials>JY</Initials><AffiliationInfo><Affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. sakyamuni_jin@163.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gu</LastName><ForeName>Ying-Xin</ForeName><Initials>YX</Initials><AffiliationInfo><Affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. yingxingu@163.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Qiao</LastName><ForeName>Shi-Chong</ForeName><Initials>SC</Initials><AffiliationInfo><Affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. shichong-qiao@hotmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhuang</LastName><ForeName>Long-Fei</ForeName><Initials>LF</Initials><AffiliationInfo><Affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. longfei_82@hotmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Xiao-Meng</ForeName><Initials>XM</Initials><AffiliationInfo><Affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. zhangxiaomengwowo@126.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lai</LastName><ForeName>Hong-Chang</ForeName><Initials>HC</Initials><AffiliationInfo><Affiliation>Department of Oral and Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhizaoju Road, Shanghai, 200011, China. lhc9@hotmail.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02350075</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>07</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015921">Dental Implants</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Clin Oral Implants Res. 2014 Jun;25(6):755-60</RefSource><PMID Version="1">23560797</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Periodontol. 2014 Feb;41(2):191-213</RefSource><PMID Version="1">24266703</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eur J Oral Implantol. 2014 Autumn;7(3):247-55</RefSource><PMID Version="1">25237669</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eur J Oral Implantol. 2014 Winter;7(4):383-95</RefSource><PMID Version="1">25422826</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Oral Implants Res. 2015 Feb;26(2):197-203</RefSource><PMID Version="1">24372993</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Periodontol. 2015 Jan;42(1):72-80</RefSource><PMID Version="1">25418606</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Implant Dent Relat Res. 2015 Feb;17(1):120-32</RefSource><PMID 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Version="1">23621393</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D001284" MajorTopicYN="N">Atrophy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002681" MajorTopicYN="N" Type="Geographic">China</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002985" MajorTopicYN="N">Clinical Protocols</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015921" MajorTopicYN="Y">Dental Implants</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017267" MajorTopicYN="N">Dental Prosthesis Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007576" MajorTopicYN="N">Jaw, Edentulous, Partially</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000601" MajorTopicYN="Y">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008437" MajorTopicYN="N">Maxilla</DescriptorName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName><QualifierName UI="Q000601" MajorTopicYN="Y">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061646" MajorTopicYN="N">Operative Time</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016348" MajorTopicYN="N">Osseointegration</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010027" MajorTopicYN="N">Osteotomy</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010149" MajorTopicYN="N">Pain, Postoperative</DescriptorName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059546" MajorTopicYN="N">Sinus Floor Augmentation</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016388" MajorTopicYN="N">Tooth Loss</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000601" MajorTopicYN="Y">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID 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