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

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: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Drug: Hyaluronic acid; Other: Steril saline solution

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ordu, Turkey (Türkiye), 52100
    • Figen Öngöz Dede

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Complete root coverage	for evaluating rate of complete root coverage	6 months postsurgery
Mean root coverage	for evaluating rate of mean root coverage	6 months postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	to assess plaque accumulation	Baseline
Gingival Index	for evaluating gingival inflammation	Baseline
Probing pocket depth	for measuring disease severity	Baseline
Plaque Index	to assess plaque accumulation	6 months post surgery
Gingival index	for evaluating gingival inflammation	6 montsh post surgery
Probing pocket depth	for measuring disease severity	6 months post surgery
Clinical attachment level	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	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	for evaluating gingival recession depth	Baseline
Vertical recession depth	for evaluating gingival recession depth	6 months postsurgery
Horizontal gingival recession	for evaluating gingival recession depth	Baseline
Horizontal gingival recession	for evaluating gingival recession depth	6 months postsurgery
Attached gingival width	for evaluating attached gingival width	Baseline
Attached gingival width	for evaluating attached gingival width	6 months postsurgery
Keratinized gingival width	for evaluating keratinized gingival width	Baseline
Keratinized gingival width	for evaluating keratinized gingival width	6 months postsurgery
Gingival thickness	for evaluating gingival thickness	Baseline
Gingival thickness	for evaluating gingival thickness	6 months postsurgery
Patient comfort score	Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".	Baseline
Patient comfort score	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	Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale	Baseline
Patient aesthetic score	Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale	6 months post surgery
Patient sensitivity score	painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale	Baseline
Patient sensitivity score	painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale	6 months postsurgery

Collaborators and Investigators

• Sponsor: Ordu University
• Investigators: Principal Investigator: Figen Öngöz Dede, Prof, Ordu Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): August 10, 2025

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession; Carbohydrates; Glycosaminoglycans; Polysaccharides; Hyaluronic Acid
• Other Study ID 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