NCT07130266

Adjunctive 0.8% Hyaluronic Acid Gel in Open-Flap Surgery for Thin Gingival Phenotype in Patients With Periodontitis

Evaluation of the Clinical and Volumetric Effectiveness of 0.8% Hyaluronic Acid Gel Adjunct to Open-Flap Surgery in Periodontitis Patients With Thin Gingival Phenotype

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the clinical effectiveness of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) in periodontitis patients with a thin gingival phenotype. The primary research question is: Does the adjunctive use of 0.8% HA gel reduce gingival recession and improve clinical parameters? To answer this, researchers will compare the adjunctive use of 0.8% HA gel to physiological saline in combination with OFD, assessing their effects on clinical outcomes and gingival recession in patients with a thin gingival phenotype. Participants will: * Receive 0.8% HA gel application during OFD surgery and a second application at 4 weeks postoperatively. * Attend follow-up visits at 1, 3, and 6 months after surgery for clinical assessments and measurements.

Detailed description

A total of 40 patients were enrolled in the study and randomly assigned to two groups: (a) OFD + 0.8% HA gel (n = 20, test group) and (b) OFD alone (n = 20, control group). Clinical parameters including plaque (P), bleeding on probing (BoP), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline. Following initial periodontal therapy, sites with PPD ≥ 5 mm and horizontal bone loss, were identified in patients with a thin gingival phenotype, determined using color-coded gingival probes. Intraoral digital scans were taken, and relative gingival recession (rGR) was recorded immediately before surgery. During OFD, the test group received adjunctive 0.8% HA gel, while the control group received physiological saline. In the test group, HA gel application was repeated at 4 weeks postoperatively. Changes in soft tissue volume (mm³) and thickness (mm) were measured using specialized computer software. Follow-up evaluations were performed at 3 and 6 months post-treatment.

Conditions

• Hyaluronic Acid
• Open Flap Debridement
• Periodontitis
• Gingival Phenotype
• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	Procedure/Surgery: Hyaluronic acid gel application	After root surface cleaning and infected cement removal, 0.8% HA gel was applied to the root surface, bone, and inner surface of the flap and left for 2 minutes.
PROCEDURE	giving an impression of the application	In the control group, instead of HA gel, the area was irrigated with physiological saline solution.

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2025-08-19
• Last updated: 2025-08-27

Locations

1 site across 1 country: Turkey (Türkiye)