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
13 juillet 2026 mis à jour par: Marcella Kahn, University of Sao Paulo
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
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
Surgical procedures and sample collections will be performed at Instituto Kahn Odontologia (Rio de Janeiro, Brazil). Laboratory analyses will be conducted at the Histology Laboratory of the School of Dentistry of Ribeirao Preto, University of Sao Paulo (FORP-USP).
SCTG removal will be performed using the double incision technique (Harris, 2003) with a standardized 1.5 mm guide scalpel, under local anesthesia (2% lidocaine, 1:100,000 epinephrine). From each graft, a standardized fragment (3×3 mm, 1.5 mm thickness) will be collected from the distal portion and immediately fixed in 10% buffered formalin for 24-48 hours, then transferred to 70% alcohol.
Laboratory analyses will include: (1) Hematoxylin-eosin (HE) for general morphological assessment; (2) Picrosirius Red under polarized light for quantification of collagen density and proportion of type I and type III collagen fibers; (3) Immunohistochemistry for vascularization assessment, measuring microvessel density (n/mm²) and vascular area (%).
Statistical analysis will use paired Student's t-test or Wilcoxon test for paired samples, depending on data distribution (Shapiro-Wilk test), with significance level of 5% (p<0.05).
Type d'étude
Interventionnel
Inscription (Estimé)
15
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Marcella Kahn, DDS, MS Candidate
- Numéro de téléphone: +5521988483846
- E-mail: mbkahn@usp.br
Sauvegarde des contacts de l'étude
- Nom: Michel Reis Messora, DDS, MS, PhD
- E-mail: m.messora@forp.usp.br
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Age between 18 and 60 years
- Good general systemic health
- Presence of multiple bilateral gingival recessions with indication for root coverage
Exclusion Criteria:
- Smoking of any intensity
- Pregnancy or lactation
- Oral lesions or alterations in the palatal mucosa
- Previous history of graft harvesting from the donor area
- Continuous use of medications that interfere with the inflammatory response, such as corticosteroids or immunosuppressants
- Autoimmune diseases, coagulation disorders, or other systemic conditions affecting wound healing
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Regenfast Gel Application Test Side
Palatal side randomized to receive a single topical application of polynucleotide and hyaluronic acid gel (Regenfast, 0.3 ml) immediately after subepithelial connective tissue graft (SCTG) harvesting in the first surgical session.
The contralateral side receives no intervention.
SCTG is harvested again from the same site after 9 weeks for histological and immunohistochemical analyses.
|
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.
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.
|
|
Comparateur actif: No Intervention - Control Side
Contralateral palatal side receiving no topical intervention after SCTG harvesting in the first surgical session.
SCTG is harvested again from the same site after 9 weeks.
This arm serves as control for both the healing time comparison (baseline vs 9 weeks) and the biomaterial effect comparison.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Histological Tissue Architecture of the Subepithelial Connective Tissue Graft
Délai: 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®).
|
Baseline and 9 weeks after initial graft harvesting
|
|
Collagen Density and Fiber Maturation of the Subepithelial Connective Tissue Graft
Délai: 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®).
|
Baseline and 9 weeks after initial graft harvesting
|
|
Microvascular Density and Vascular Area of the Subepithelial Connective Tissue Graft
Délai: 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®).
|
Baseline and 9 weeks after initial graft harvesting
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Marcella B Kahn, DDS, MS Candidate, Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)
- Chaise d'étude: Michel Reis Messora, DDS, MS, PhD, Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP) Role: Study Chair
- Directeur d'études: Sergio Kahn, DDS, MS, PhD, Instituto Kahn Odontologia, Rio de Janeiro
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
- Harris RJ. The connective tissue and partial thickness double pedicle graft: a predictable method of obtaining root coverage. J Periodontol. 1992 May;63(5):477-86. doi: 10.1902/jop.1992.63.5.477.
- Pilloni A, Rojas MA, Trezza C, Carere M, De Filippis A, Marsala RL, Marini L. Clinical effects of the adjunctive use of polynucleotide and hyaluronic acid-based gel in the subgingival re-instrumentation of residual periodontal pockets: A randomized, split-mouth clinical trial. J Periodontol. 2023 Mar;94(3):354-363. doi: 10.1002/JPER.22-0225. Epub 2022 Nov 23.
- Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.
- Tavelli L, Barootchi S, Siqueira R, Kauffmann F, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Three-Dimensional Volumetric Analysis of the Palatal Donor Site Following Soft Tissue Harvesting. Int J Periodontics Restorative Dent. 2022 May-Jun;42(3):393-399. doi: 10.11607/prd.5268.
- Harris RJ. Histologic evaluation of connective tissue grafts in humans. Int J Periodontics Restorative Dent. 2003 Dec;23(6):575-83.
- Cairo F, Cavalcanti R, Barbato L, Nieri M, Castelluzzo W, di Martino M, Pilloni A. Polynucleotides and Hyaluronic Acid (PN-HA) Mixture With or Without Deproteinized Bovine Bone Mineral as a Novel Approach for the Treatment of Deep Infrabony Defects: A Retrospective Case Series. Int J Periodontics Restorative Dent. 2025 Mar 6;45(2):153-163. doi: 10.11607/prd.7065.
- Skierska I, Gorski B, Fus L. Tunnel technique and subepithelial connective tissue graft, with or without cross-linked hyaluronic acid, in the treatment of multiple gingival recessions: 12-month outcomes of a randomized clinical trial. J Periodontol. 2024 Nov;95(11):1060-1072. doi: 10.1002/JPER.24-0093. Epub 2024 May 29.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
31 octobre 2026
Achèvement de l'étude (Estimé)
27 février 2027
Dates d'inscription aux études
Première soumission
1 juillet 2026
Première soumission répondant aux critères de contrôle qualité
13 juillet 2026
Première publication (Réel)
16 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 95625625.9.0000.5419 (Autre identifiant: Plataforma Brasil)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared.
Participant confidentiality is ensured through numerical coding, and all collected data will be used exclusively for scientific purposes within the scope of this study, in accordance with the ethical principles of the Declaration of Helsinki and the approved protocol.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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