NCT06842511

Effects of the Adjunctive Use of Hyaluronic Acid-based Gel in the Surgical Periodontal Treatment of Periodontitis

Effects on the Anti-inflammatory and Antioxidant Levels of the Adjunctive Use of Hyaluronic Acid-based Gel in the Surgical Periodontal Treatment of Stage III Periodontitis Patients: A Randomized, Split-mouth Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ordu University · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to assess the effect of Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent in surgical periodontal treatment on clinical parameters and cytokine levels (IL-6, IL-8, IL-10, IL-17A, TOS, and TAS) in gingival crevicular fluid (GCF) among periodontitis patients.

Detailed description

The aim of this study is to evaluate the effects of adjunctive Hyaluronic Acid-Based Gel (HA) application in the surgical treatment of patients with moderate to severe stage III periodontitis (Grade B or C) on clinical parameters, as well as on IL-6, IL-8, IL-10, IL-17, TAS, and TOS levels in gingival crevicular fluid (GCF) to determine its anti-inflammatory and antioxidant efficacy. This split-mouth study included 18 patients (mean age 43.44±8.12 years) diagnosed with Stage III Grade B or C periodontitis. Quadrants were randomly assigned to two groups: Group 1 (control: open flap debridement \[OFD\], n=18) and Group 2 (test: OFD + 0.8% HA gel, n=18). Baseline (T0) assessments included plaque index (PI), gingival index (GI), bleeding on probing index (BPI), probing pocket depth (PPD), clinical attachment level (CAL), and GCF collection. Following non-surgical treatment, patients underwent OFD; HA gel was applied to defect sites in the test group and saline in the control. Clinical parameters and GCF sampling were repeated pre-surgery (TS-1), and at 1 month (TS-2) and 6 months (TS-3) post-surgery.

Conditions

• Periodontitis (Stage 3)

Interventions

Type	Name	Description
DRUG	open flap debridement and Hyaluronic Acid-Based Gel application	Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent
PROCEDURE	open flap debridement	periodontal surgery technique

Timeline

• Start date: 2023-04-04
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: Turkey (Türkiye)