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Clinical Trials/NCT06208254
NCT06208254
Not yet recruiting
Not Applicable

Prevalence and Risk Indicators of Peri-implant Diseases in China: A Multicenter Cross-sectional Study

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 sites500 target enrollmentJanuary 31, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment
500
Primary Endpoint
Bleeding on probing [positive (+) or negative (-)]
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this multicenter cross-sectional study is to investigate the prevalence of peri-implantitis in China. The main questions it aims to answer are:

  • What is the prevalence of peri-implantitis in China
  • What are the risk indicators of peri-implantitis in China

Participants will be invited to a free-of-charge clinical and radiographic examination of conventional dental implants present for over 5 years.

Registry
clinicaltrials.gov
Start Date
January 31, 2024
End Date
January 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients having at least one rough surface titanium implant in function for more than 5 years
  • Patients treated between January 1, 2013 and December 31, 2017
  • All the implants osseointegrated in the patients' mouth at the time of the examination (including those placed in external clinics) and having at least 5 years of loading, either proven by dental charts or confirmed by the patients, were evaluated

Exclusion Criteria

  • Selected patients were invited to participate in the study by telephone calls on the numbers reported in their medical records, and if no response, the patient was not discarded until at least five attempts on different days have been made
  • Periapical and/or panoramic radiographs unavailable
  • History of peri-implantitis and/or peri-implant mucositis treatment
  • Refusal to participate in the study

Outcomes

Primary Outcomes

Bleeding on probing [positive (+) or negative (-)]

Time Frame: About 5-10 years after surgery

When bleeding is present after probing using a periodontal probe with a force of 0.2-0.3 N.

Peri-implant probing depth (mm)

Time Frame: About 5-10 years after surgery

Measured using a periodontal probe inserted into the peri-implant sulcus

Bone loss (mm)

Time Frame: About 5-10 years after surgery

Measured apically from the most coronal portion of the intraosseous part of the implant using periapical radiographs

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