Gingival Recession, GeneralizedNCT07708051
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 study testing polynucleotide and hyaluronic acid gel and subepithelial connective tissue graft harvesting in people with Gingival Recession, Generalized and Gingival Recession, Localized, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession, Generalized, Gingival Recession, Localized, Wound Healing
- What is being tested?
- polynucleotide and hyaluronic acid gel and subepithelial connective tissue graft harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to 27 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Good general systemic health
- Presence of multiple bilateral gingival recessions with indication for root coverage
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Michel Reis Messora, DDS, MS, PhD contact
About this study
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
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.
Read the detailed description
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).
- Conditions
- Gingival Recession, Generalized, Gingival Recession, Localized, Wound Healing, Palate; Wound
- Being tested
- polynucleotide and hyaluronic acid gel, subepithelial connective tissue graft harvesting
- Keywords
- Subepithelial connective tissue graft, Palatal donor site, Wound healing, Gingival Recession, Hyaluronic acid, Polynucleotides, Split-mouth clinical trial, Histological analysis
- Medical subject headings
- Gingival Recession, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polynucleotide and hyaluronic acid gelDrug
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 harvestingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Regenfast Gel Application Test Side | Experimental | 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. Receives: Drug: polynucleotide and hyaluronic acid gel; Procedure: subepithelial connective tissue graft harvesting |
| No Intervention - Control Side | Active comparator | 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. Receives: Procedure: subepithelial connective tissue graft harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®).
Measured: Baseline and 9 weeks after initial graft harvesting
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®).
Measured: Baseline and 9 weeks after initial graft harvesting
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®).
Measured: Baseline and 9 weeks after initial graft harvesting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Kahn Odontologia
- Responsible party
- Principal investigator, Marcella Kahn, University of Sao Paulo
- Investigators
- Marcella B Kahn, DDS, MS Candidate, Principal investigator, Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)Michel Reis Messora, DDS, MS, PhD, Study chair, Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP) Role: Study ChairSergio Kahn, DDS, MS, PhD, Study director, Instituto Kahn Odontologia, Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708051
- Sponsor's protocol ID
- 95625625.9.0000.5419
- Other IDs
- 95625625.9.0000.5419
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Harris RJ. Histologic evaluation of connective tissue grafts in humans. Int J Periodontics Restorative Dent. 2003 Dec;23(6):575-83.
PubMed 14703761Harris 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.
PubMed 1527693Cairo 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.
PubMed 38363180Pilloni 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.
PubMed 36189651Skierska 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.
PubMed 38808976Tavelli 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.
PubMed 36583690Tavelli 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.
PubMed 35472117Soileau 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.
PubMed 16805692