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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07437885
Enrollment
20
Registered
2026-02-27
Start date
2024-09-01
Completion date
2025-08-10
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Brief summary

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.

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.

Interventions

DRUGHyaluronic acid

0.8% hyaluronic acid gel (Gengigel Oral Forte Gel, Ricefarma, Milan, Italy)

OTHERSteril saline solution

Mix 8 teaspoons of salt into 4 L of distilled water

Sponsors

Ordu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Double-sided type 1 gingival recession * No inflammation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Complete root coverage6 months postsurgeryfor evaluating rate of complete root coverage
Mean root coverage6 months postsurgeryfor evaluating rate of mean root coverage

Secondary

MeasureTime frameDescription
Plaque IndexBaselineto assess plaque accumulation
Gingival IndexBaselinefor evaluating gingival inflammation
Gingival index6 montsh post surgeryfor evaluating gingival inflammation
Probing pocket depthBaselinefor measuring disease severity
Clinical attachment levelBaselineClinical 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.
Vertical recession depthBaselinefor evaluating gingival recession depth
Horizontal gingival recessionBaselinefor evaluating gingival recession depth
Attached gingival widthBaselinefor evaluating attached gingival width
Keratinized gingival widthBaselinefor evaluating keratinized gingival width
Gingival thicknessBaselinefor evaluating gingival thickness
Patient comfort scoreBaselinePatient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".
Patient aesthetic scoreBaselinePoor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale
Patient sensitivity scoreBaselinepainless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORFigen Öngöz Dede, Prof

Ordu Universitesi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026