Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

Recruiting

• Conditions: Peri-Implantitis

• Registration Number: NCT05339789
• Lead Sponsor: Malmö University

Brief Summary

The surgical treatment outcome of patients that have been or are consecutively treated at the University of Malmö, at Blekinge hospital, and at the Dental Clinic of the Sigmund Freud University Vienna will be evaluated on an a regular base; specifically all patients treated since 2014 and those receiving treatment in the future, will be regularly assessed, max. once per year after the 1-year control from the surgical intervention for clinical and radiographic assessment of healing. Clinical peri-implant parameters (e.g., probing pocket depth) and peri-implant sulcus fluid (PISF) are collected, and a peri-apical radiographic examination is made. Further, from 200 patients treated in the future, the inflammatory peri-implant lesion will be collected and subjected to histological, microbiological, and molecular analysis. The removal of these lesions is a standard procedure and performed in all patients independent of study participation; i.e., the lesion has anyway to be removed during surgery and if the lesions are not stored, they would be thrown.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-30
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• All patients being treated since 2014 and continuously being treated will be called in for regular check-ups after the surgical intervention and an examination for study purpose will be performed annually.

Exclusion criteria:

• implant loss

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease resolution (Binary: yes/no)	120 months postoperative	Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.

Trial Locations

Locations (3)

Dental Clinic, Sigmund Freud University Vienna; 🇦🇹 Vienna, Austria

Blekinge hospital; 🇸🇪 Karlskrona, Sweden

Malmö University; 🇸🇪 Malmö, Sweden