Prevalence and Risk Indicators of Peri-implant Diseases in China

NCT06208254 | Unknown

• 1 other identifier: SDC-23-3
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (3)

• 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

• Peri-implant probing depth (mm)

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

  About 5-10 years after surgery

• 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

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who have conventional dental implants placed and over 5 years of functional loading.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yiqun Wu

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinbo Yu

CONTACT

18019409340; xinboyu@proton.me

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 17, 2024
• Study Start: January 31, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2023-12