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NCT07918326
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Conditions: Gingival Graft, Recession, Gingival, Platelet Rich Fibrin
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 48
Sponsor: G. d'Annunzio University
Location: Department of Innovative Technologies in Medicine and Dentistry, University 'G. D'Annunzio' of Chieti Chieti Chieti
Summary
This study aims to evaluate the efficacy of a novel bioactive matrix, consisting of an equine collagen core soaked in i-PRF and wrapped in L-PRF, used in combination with a coronally advanced flap as an alternative to the autologous connective tissue graft for the treatment of gingival recessions. In this randomized controlled clinical trial, 24 patients with Miller Class I or II recessions will be treated with either the bioactive matrix (test) or a subepithelial connective tissue graft (control), with calibrated and blinded examiners. The primary endpoints are mean and complete root coverage at 6 months, while secondary outcomes include clinical parameters and patient-reported outcome measures (PROMs) on post-operative discomfort and satisfaction, recorded at baseline, 3 and 6 months.
Eligibility Criteria
Inclusion criteria Age ≥ 18 years Systemically healthy non-smokers Willingness to provide informed consent and attend the study No antibiotic use within the previous 3 months No known allergies to the materials used in the study No periodontal plastic surgery at the defect site within the previous 12 months Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 20% Miller Class I or II (RT1) buccal gingival recessions at maxillary or mandibular incisors, canines or premolars, single or multiple Recession depth ≥ 2 mm Exclusion criteria Unstable systemic diseases Compromised healing potential (e.g. diabetes) Active infectious diseases (hepatitis, tuberculosis, HIV, etc.) Use of steroid medications Pregnancy or attempting to become pregnant Use of medications known to cause gingival enlargement
Source: ClinicalTrials.gov (NCT07918326). StuddyBuddy aggregates publicly available trial information.