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Clinical Trials/NCT05339789
NCT05339789
Recruiting
Not Applicable

Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

Malmö University3 sites in 2 countries650 target enrollmentAugust 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
Malmö University
Enrollment
650
Locations
3
Primary Endpoint
Disease resolution (Binary: yes/no)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2020
End Date
December 31, 2030
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Malmö University
Responsible Party
Principal Investigator
Principal Investigator

Kristina Bertl

Principal Investigator

Malmö University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Disease resolution (Binary: yes/no)

Time Frame: 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.

Study Sites (3)

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