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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Sao Paulo

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

Qualifiers

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

Treatments tested in this trial

  • polynucleotide and hyaluronic acid gel
  • subepithelial connective tissue graft harvesting

Treatment groups

15 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Sao Paulo

Lead sponsor

Instituto Kahn Odontologia

Collaborator