Effects of the Adjunctive Use of Hyaluronic Acid-based Gel With Coranally Advanced Flap in the Gingival Recession

February 26, 2026 updated by: Prof.Dr. Figen ÖNGÖZ DEDE, Ordu University

Clinical Efficacy and Patient Experience of Adjunctive Hyaluronic Acid-based Gel Application With Coronally Advanced Flap in Type 1 Gingival Recession: A Randomized Controlled Clinical Trial

The study aimed to evaluate the effect of Hyaluronic Acid-based gel use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months.

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.

Detailed Description

The aim of this study is to evaluate the effect of HA use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months.

This split-mouth study included 20 patients (9 males, 11 females) with a mean age of 42.10±9.46 years who were diagnosed with bilateral RT1 gingival recession in the maxilla. The right and left defect areas of the 20 patients were randomly assigned to two groups. The control group received CAF (n=20), and the test group received CAF+HA (n=20). Pre-treatment plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), vertical recession depth (VRD), horizontal recession width (HRW), gingival thickness (GT), attached gingival (AG), and keratinized gingival width (KGW) were recorded. Additionally, a satisfaction analysis was conducted, including patient-based comfort (PBC), aesthetic (PEA), and sensitivity (PHS) scores. During the operation, a 0.8% HA gel was applied to the defect areas in the test group, in addition to CAF, while saline was applied to the control group, also in addition to CAF. Pain, bleeding, and edema scores, as well as the amount of painkillers, were recorded during the 9-day postoperative period. Clinical parameter measurements and patient satisfaction analyses were repeated 6 months after surgical treatment.

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.
20

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.
  • Phase 2
  • Phase 1

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

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Double-sided type 1 gingival recession
  • No inflammation

Exclusion Criteria:

  • active periodontal disease
  • smokers
  • pregnant and breastfeeding women
  • individuals with unilateral GR

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: Single

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.
Active Comparator: Coranally Advanced Flap and Hyaluronic Acid-Based Gel application
Coronally advanced flap and adjunctive use of 0.8% hyaluronic acid-based gel
Drug: Hyaluronic acid
0.8% hyaluronic acid gel (Gengigel Oral Forte Gel, Ricefarma, Milan, Italy)
Placebo Comparator: Coranally Advanced Flap
Only Coronally advanced flap
Other: Steril saline solution
Mix 8 teaspoons of salt into 4 L of distilled water

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
Complete root coverage
Time Frame: 6 months postsurgery
for evaluating rate of complete root coverage
6 months postsurgery
Mean root coverage
Time Frame: 6 months postsurgery
for evaluating rate of mean root coverage
6 months postsurgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: Baseline
to assess plaque accumulation
Baseline
Gingival Index
Time Frame: Baseline
for evaluating gingival inflammation
Baseline
Probing pocket depth
Time Frame: Baseline
for measuring disease severity
Baseline
Plaque Index
Time Frame: 6 months post surgery
to assess plaque accumulation
6 months post surgery
Gingival index
Time Frame: 6 montsh post surgery
for evaluating gingival inflammation
6 montsh post surgery
Probing pocket depth
Time Frame: 6 months post surgery
for measuring disease severity
6 months post surgery
Clinical attachment level
Time Frame: Baseline
Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.
Baseline
Clinical attachment level
Time Frame: 6 months post surgery
Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.
6 months post surgery
Vertical recession depth
Time Frame: Baseline
for evaluating gingival recession depth
Baseline
Vertical recession depth
Time Frame: 6 months postsurgery
for evaluating gingival recession depth
6 months postsurgery
Horizontal gingival recession
Time Frame: Baseline
for evaluating gingival recession depth
Baseline
Horizontal gingival recession
Time Frame: 6 months postsurgery
for evaluating gingival recession depth
6 months postsurgery
Attached gingival width
Time Frame: Baseline
for evaluating attached gingival width
Baseline
Attached gingival width
Time Frame: 6 months postsurgery
for evaluating attached gingival width
6 months postsurgery
Keratinized gingival width
Time Frame: Baseline
for evaluating keratinized gingival width
Baseline
Keratinized gingival width
Time Frame: 6 months postsurgery
for evaluating keratinized gingival width
6 months postsurgery
Gingival thickness
Time Frame: Baseline
for evaluating gingival thickness
Baseline
Gingival thickness
Time Frame: 6 months postsurgery
for evaluating gingival thickness
6 months postsurgery
Patient comfort score
Time Frame: Baseline
Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".
Baseline
Patient comfort score
Time Frame: 6 months postsurgery
Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".
6 months postsurgery
Patient aesthetic score
Time Frame: Baseline
Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale
Baseline
Patient aesthetic score
Time Frame: 6 months post surgery
Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale
6 months post surgery
Patient sensitivity score
Time Frame: Baseline
painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale
Baseline
Patient sensitivity score
Time Frame: 6 months postsurgery
painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale
6 months postsurgery

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.
Ordu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Figen Öngöz Dede, Prof, Ordu 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.
September 1, 2024

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.
July 30, 2025

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.
August 10, 2025

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).
February 20, 2026

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.
February 26, 2026

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.
February 27, 2026

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.
February 27, 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.
February 26, 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.
February 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.
  • 2024/178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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