Hyaluronic Acid With Connective Tissue Grafting for Gingival Recession

July 20, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Hyaluronic Acid (0.8%) - Applied over CTG before flap closure (Test group only).
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
Procedure: Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)
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.
Procedure: Connective Tissue Graft + Coronally Advanced Flap (CTG + CAF)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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