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

T.C. ORDU ÜNİVERSİTESİ

Status and phase: Completed; Phase 2; Phase 1

Conditions: Periodontitis (Stage 3)

Treatments: Procedure: open flap debridement; Drug: open flap debridement and Hyaluronic Acid-Based Gel application

Study type: Interventional

Funder types: Other

Identifiers

NCT06842511

77158231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage III Grade B or C periodotitis
• over 18 years old
• signed the informed consent

Exclusion criteria

• pregnancy, or lactation,
• systemic problems that would contraindicate for periodontal surgery,
• prosthetic restorations in the test or control teeth,
• taking medications that affect wound healing (corticosteroids, anticancer agents, etc),
• using nonsteroidal anti-inflammatory drugs, using any antibiotics and anti-inflammatory drugs in the last 6 months,
• alcohol abuse and smoking use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

only open flap debridement

Treatment:

Procedure: open flap debridement

Test group

Active Comparator group

Description:

open flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel

Treatment:

Procedure: open flap debridement

Drug: open flap debridement and Hyaluronic Acid-Based Gel application