- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291583
Hyaluronic Acid With Connective Tissue Grafting for Gingival Recession
December 20, 2025 updated by: Şeyma Çardakçı, Saglik Bilimleri Universitesi
Clinical and Aesthetic Evaluation of Hyaluronic Acid in Addition to Connective Tissue Grafts in the Treatment of Gingival Recession Defects
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
None Selected
-
Ankara, None Selected, Turkey (Türkiye), 6220
- University of Health Sciences, Gülhane Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental - CTG + Hyaluronic Acid
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.
|
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
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.
|
|
Active Comparator: CTG only
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Adjunctive Hyaluronic Acid on Mean Root Coverage After Recession Treatment
Time Frame: From enrollment to the end of treatment at 6 months"
|
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"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
December 5, 2025
First Submitted That Met QC Criteria
December 5, 2025
First Posted (Estimated)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 20, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Seyma9319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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