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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • polynucleotide and hyaluronic acid gel

    Drug

    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.

  • subepithelial connective tissue graft harvesting

    Procedure/Surgery

    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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Regenfast Gel Application Test SideExperimental treatment 2 interventions
Group B: No Intervention - Control SideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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®).

Time frame
Baseline and 9 weeks after initial graft harvesting
2

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®).

Time frame
Baseline and 9 weeks after initial graft harvesting
3

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®).

Time frame
Baseline and 9 weeks after initial graft harvesting

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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University of Sao Paulo

Lead sponsor

Instituto Kahn Odontologia

Collaborator

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