Comparison of Fibro-Gide Collagen Matrix and Connective Tissue Graft Surgery for Treating Multiple Gum Recessions with Coronally Advanced Flap

What this Trial Is About

This research aims to evaluate a new treatment for covering multiple adjacent gingival recession defects. The study compares the standard surgical method using soft tissue taken from the roof of the mouth with a synthetic collagen matrix called Fibro-Gide. The goal is to see if the collagen matrix can provide similar root coverage while potentially reducing the extent of surgery, pain, and discomfort. This trial is a randomized, multicenter, controlled study conducted in academic and practice-based centers across Italy, Germany, and Spain. Participants will receive root coverage surgery using coronally advanced flaps combined either with the volume stable collagen matrix Fibro-Gide or with an autologous connective tissue graft harvested from the patients palate. Treatments will be standardized and delivered by experienced clinicians. The study includes two groups one receiving the collagen matrix and the other receiving the standard connective tissue graft. Follow-up will last up to 1 year with an additional long-term observation of 3 years for extended data collection. During the study, participants will undergo clinical evaluations of root coverage and aesthetics by blinded examiners at each center. Patient questionnaires and diaries will be used to assess recovery time and quality of life related to oral health at multiple time points up to 36 months. Safety and adverse events, including complete root coverage and professional aesthetic assessments, will be monitored. The primary outcome is root coverage after 12 months, with secondary outcomes including complete root coverage, time to recovery, and oral health quality of life measures.

Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.