Hyaluronic Acid With Connective Tissue Grafting for Gingival Recession

NCT07291583 | Active Not Recruiting

• 1 other identifier: Seyma9319
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether adding 0.8% hyaluronic acid (HA) to connective tissue grafting and coronally advanced flap surgery improves clinical and esthetic outcomes in the treatment of gingival recession. Adult patients with Miller I-II or Cairo RT1 recession defects will be randomly assigned to receive CTG alone or CTG with adjunctive HA. Mean root coverage at 6 months is the primary outcome, while secondary measures include gingival thickness, clinical attachment level, esthetic scores, postoperative morbidity, and quality of life. The study aims to determine whether HA enhances soft tissue healing and root coverage predictability compared with conventional CTG.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Impact of Adjunctive Hyaluronic Acid on Mean Root Coverage After Recession Treatment

  The primary objective of this study is to evaluate the effect of adjunctive hyaluronic acid (HA) on the mean root coverage (MRC) achieved after the treatment of gingival recession defects.

  From enrollment to the end of treatment at 6 months"

Study Arms (2)

Experimental - CTG + Hyaluronic Acid

EXPERIMENTAL

A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance.

Biological: Hyaluronic Acid (0.8%) - Applied over CTG before flap closure (Test group only).; Procedure: Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)

CTG only

ACTIVE COMPARATOR

A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.

Procedure: Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)

Interventions

Hyaluronic Acid (0.8%) - Applied over CTG before flap closure (Test group only). BIOLOGICAL

A 0.8% hyaluronic acid (HA) gel is applied to the connective tissue graft (CTG) before flap closure during the coronally advanced flap (CAF) procedure. The HA gel is used as an adjunctive biologic material to potentially enhance wound healing, soft tissue thickness, esthetic outcomes, and overall root coverage performance

Experimental - CTG + Hyaluronic Acid

Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF) PROCEDURE

A standardized coronally advanced flap (CAF) procedure combined with a subepithelial connective tissue graft (CTG) is performed to treat gingival recession defects. The surgical protocol includes flap elevation, graft harvesting and placement, and flap advancement and suturing.

CTG only; Experimental - CTG + Hyaluronic Acid

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least one gingival recession defect classified as Cairo RT1 or Miller Class I-II with a minimum depth of 1 mm.
• Full-mouth plaque score (FMPS) and full-mouth bleeding on probing (FMBOP) \< 15%.
• Detectable cemento-enamel junction (CEJ).
• Age ≥ 18 years.
• No history of prior periodontal surgical treatment.
• Sufficient mental capacity to understand the study aims and procedures explained verbally and in writing.
• Determined to be cooperative and compliant with the clinician before, during, and after the surgical procedure.

You may not qualify if:

• Patients younger than 18 years.
• Periodontally healthy individuals.
• Current smokers.
• History of periodontal treatment within the past 1 year.
• Use of antibiotics within the past 3 months.
• Pregnancy or breastfeeding.
• Presence of systemic diseases such as diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, or other chronic conditions; and gingival recessions classified as Cairo RT3.
• Presence of cervical caries or restorations at the defect site.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences, Gülhane Faculty of Dentistry

Ankara, None Selected, 6220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asst. professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

TU (1)