Prevalence and Risk Indicators of Peri-implant Diseases in China
January 15, 2024 updated by: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Prevalence and Risk Indicators of Peri-implant Diseases in China: A Multicenter Cross-sectional Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinbo Yu
- Phone Number: 18019409340
- Email: xinboyu@proton.me
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult patients who have conventional dental implants placed and over 5 years of functional loading.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients
Patients having at least one rough surface titanium implant in function for more than 5 years.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
About 5-10 years after surgery
|
|
Peri-implant probing depth (mm)
Time Frame: About 5-10 years after surgery
|
Measured using a periodontal probe inserted into the peri-implant sulcus
|
About 5-10 years after surgery
|
|
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
|
About 5-10 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yiqun Wu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 31, 2024
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
January 3, 2024
First Submitted That Met QC Criteria
January 15, 2024
First Posted (Actual)
January 17, 2024
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 15, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDC-23-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.