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Studies

Interventional Not yet recruiting

NCT07708051 on ClinicalTrials.gov

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

Official title: 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: A Randomized, Blinded, Controlled Clinical Trial With a Split-Mouth Design

  • Sponsor: Universidade de São Paulo
  • Collaborators: Instituto Kahn Odontologia
  • Enrollment: 15 (Estimated)
  • Study start: 2026-07-01 (Estimated)
  • Primary completion: 2026-10-31 (Estimated)
  • Study completion: 2027-02-27 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Split-mouth design in which each participant contributes two simultaneous treatment sites (left and right palate). One randomized side receives a single topical application of Regenfast® (polynucleotide and hyaluronic acid gel) after the first SCTG harvest; the contralateral side receives no intervention and serves as control. Both sides are harvested again after 9 weeks, allowing paired intraindividual comparisons.
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • PrimaryPurpose: Basic Science

Brief 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.

Conditions

  • Gingival Recession, Generalized
  • Gingival Recession, Localized
  • Wound Healing
  • Palate; Wound

Intervention / Treatment

  • Drug: polynucleotide and hyaluronic acid gel
  • Procedure: subepithelial connective tissue graft harvesting

Primary Outcome Measures

  • Histological Tissue Architecture of the Subepithelial Connective Tissue Graft (Baseline and 9 weeks after initial graft harvesting)
    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 (Baseline and 9 weeks after initial graft harvesting)
    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 (Baseline and 9 weeks after initial graft harvesting)
    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®).

Study Officials