Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease
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|ClinicalTrials.gov Identifier: NCT02676661|
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : February 8, 2016
|Condition or disease|
|Jaw, Edentulous, Partially|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||350 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2022|
no peri-implant disease
The subjects who did not suffer from peri-implant disease.
The subjects who suffered from peri-implant disease.
- peri-implant disease [ Time Frame: at the 5 years after prosthetic loading. ]Peri-implant disease includes Peri-implant mucositis and Peri-implantitis.Peri-implant mucositis: BoP/suppuration but no detectable bone loss. Peri-implantitis: BoP/suppuration and bone loss >2 mm.
- Gingival Bleeding on Probing [ Time Frame: at the first day,6 months 1,3 and 5 years after prosthetic loading. ]Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
- Pocket depths [ Time Frame: at the first day,6 months 1,3 and 5 years after prosthetic loading. ]PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm).
- Marginal bone loss [ Time Frame: at the first day,6 months 1,3 and 5 years after prosthetic loading. ]Marginal bone loss will be assessed by periapical radiographs taken with the paralleling technique.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676661
|Contact: Jihua Chen, PhDemail@example.com|
|Contact: Min Tian, PhDfirstname.lastname@example.org|
|Stomatological Hospital of Fourth Military Medical University||Recruiting|
|Xi'an, Shanxi, China, 710032|
|Contact: Min Tian, PhD +86 13891862298 email@example.com|
|Contact: Jihua Chen, PhD +86 13991390388 firstname.lastname@example.org|
|Sub-Investigator: Min Tian, PhD|
|Principal Investigator:||Yongjin Chen, PhD||IRB of Stomatological Hospital of FMMU,PLA|