About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 60 years
Good general systemic health
Presence of multiple bilateral gingival recessions with indication for root coverage
Disqualifiers
Smoking of any intensity
Pregnancy or lactation
Oral lesions or alterations in the palatal mucosa
Previous history of graft harvesting from the donor area
Trial design
Parallel
Treatments tested in this trial
polynucleotide and hyaluronic acid gel
DrugSingle topical application of polynucleotide and hyaluronic acid gel (Regenfast, 0.3 ml) to the palatal donor site immediately after subepithelial connective tissue graft harvesting in the first surgical session, before suturing.
subepithelial connective tissue graft harvesting
Procedure/SurgeryBilateral subepithelial connective tissue graft harvesting from the palatal donor site using the double incision technique (Harris, 2003) with a standardized 1.5 mm guide scalpel, under local anesthesia (2% lidocaine with 1:100,000 epinephrine). Performed in two surgical sessions with a 9-week interval.
Treatment groups
Trial outcomes
Primary outcomes
Histological Tissue Architecture of the Subepithelial Connective Tissue Graft
Morphological evaluation of tissue architecture using hematoxylin-eosin (HE) staining, assessing cellular organization, connective tissue maturation, and overall structural quality of grafts harvested at baseline and 9 weeks after initial harvesting, with and without topical application of polynucleotide and hyaluronic acid gel (Regenfast®).
Collagen Density and Fiber Maturation of the Subepithelial Connective Tissue Graft
Quantification of collagen density and proportion of type I and type III collagen fibers using Picrosirius Red staining under polarized light microscopy, comparing grafts harvested at baseline and 9 weeks after initial harvesting, with and without topical application of polynucleotide and hyaluronic acid gel (Regenfast®).
Microvascular Density and Vascular Area of the Subepithelial Connective Tissue Graft
Immunohistochemical evaluation of vascularization, assessing microvessel density (number/mm²) and vascular area (%) of grafts harvested at baseline and 9 weeks after initial harvesting, with and without topical application of polynucleotide and hyaluronic acid gel (Regenfast®).
Locations
Sponsors and contacts
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University of Sao Paulo
Lead sponsor
Instituto Kahn Odontologia
Collaborator
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