Clinical Trial

Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel

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Summary
This study evaluates whether a 9-week healing interval is sufficient for subepithelial connective tissue graft (SCTG) maturation after palatal harvesting, and whether topical application of a polynucleotide and hyaluronic acid gel (Regenfast®) improves tissue quality. This is a randomized, blinded, controlled clinical trial with a split-mouth design involving 15 participants. Each participant undergoes bilateral SCTG harvesting from the palate in two surgical sessions 9 weeks apart. In the first session, one randomized side receives a single topical application of Regenfast® after graft removal; the contralateral side serves as control. Standardized tissue fragments (3×3 mm, 1.5 mm thickness) are collected from each graft for histological (HE, Picrosirius Red) and immunohistochemical analyses. Comparisons are made between grafts collected at baseline and after 9 weeks, and between sides treated with or without the gel.
Trial Details
NCT Number NCT07708051
Lead Sponsor University of Sao Paulo
Collaborators: Instituto Kahn Odontologia
Conditions Gingival Recession, Generalized, Gingival Recession, Localized, Wound Healing, Palate; Wound
Enrollment 15 participants
Start Date 2026-07
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-02-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-16