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Reconstructive Treatment of Peri-implantitis With Combined Defects

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 4, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
171 trials monitored
See 4 trials at risk
The aim of this randomized clinical study is to assess the additional clinical benefit of incorporating a resorbable collagen membrane (CM) alongside a xenogeneic bone graft-specifically, deproteinized bovine bone mineral with 10% collagen (DBBM-C)-in the reconstructive surgical treatment of peri-implantitis involving combined (i.e., contained and non-contained) defect configurations. Accordingly, the study addresses the following research questions: * Does the adjunctive use of a CM in combination with DBBM-C improve treatment success compared to DBBM-C alone in the management of combined peri-implantitis-related defects? * Does the combined use of a CM and DBBM-C lead to superior patient-reported outcomes (PROs) compared to the use of DBBM-C alone in the reconstructive treatment of such defects? A total of 60 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive test (DBMM-C +CM) or control group (DBMM-C) treatments. Clinical parameters will be assessed at baseline (i.e., prior to surgery), and at the 6-, and 12-month post-operatively. Radiographic examinations will be carried out at baseline and 12 months post-operatively. Patient oral health related to the treatment procedures will be evaluated using a written questionnaire \[Oral Health Impact Profile (OHIP-14)\] prior to treatment and after 2 weeks, 1, and 12 months following surgical therapy. Regarding post-treatment pain and overall patient satisfaction with treatment modalities, responses will be scored on a visual analog scale (VAS, 100 mm).
Trial Details
NCT Number NCT06957652
Lead Sponsor Gazi University
Conditions
(from sponsor)
Peri-implantitis
Related terms Peri-Implantitis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov