Clinical Trial: Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study

Brief Summary: To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.

Detailed Summary: The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.
Sponsor: Fourth Military Medical University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: January 24, 2016
Date Started: October 2014
Date Completion: December 2022
Last Updated: February 5, 2016
Last Verified: January 2016