Prevalence and Risk Indicators of Peri-implant Diseases in China

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208254
• Other study ID #: SDC-23-3
• Status: Not yet recruiting
• Start date: January 31, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Xinbo Yu
• Phone: 18019409340
• Email: xinboyu[@]proton.me
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients having at least one rough surface titanium implant in function for more than 5 years

2. Patients treated between January 1, 2013 and December 31, 2017

3. 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:

1. 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

2. Periapical and/or panoramic radiographs unavailable

3. History of peri-implantitis and/or peri-implant mucositis treatment

4. Refusal to participate in the study

Related Conditions & MeSH terms

• Peri-Implantitis

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Dalian Medical University, Hong Kong Brånemark Osseointegration Center, Hospital of Stomatology, Sun Yat-Sen University, Hospital of Stomatology, Wuhan University, Nanchang University, Ningxia Medical University, Shanxi Medical University, Zunyi Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing [positive (+) or negative (-)]	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
Primary	Peri-implant probing depth (mm)	Measured using a periodontal probe inserted into the peri-implant sulcus	About 5-10 years after surgery
Primary	Bone loss (mm)	Measured apically from the most coronal portion of the intraosseous part of the implant using periapical radiographs	About 5-10 years after surgery