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

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

Interventions

DRUG

polynucleotide and hyaluronic acid gel

Single 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.

PROCEDURE

subepithelial connective tissue graft harvesting

Bilateral 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.

Sponsors & Collaborators

• Instituto Kahn Odontologia

  collaborator UNKNOWN

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Marcella B Kahn, DDS, MS Candidate · Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)

• Michel Reis Messora, DDS, MS, PhD · Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP) Role: Study Chair

• Sergio Kahn, DDS, MS, PhD · Instituto Kahn Odontologia, Rio de Janeiro

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2026-10-31

Completion

2027-02-27