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

NCT ID: NCT06842511

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2024-05-30

Brief Summary

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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

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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

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Periodontitis (Stage 3)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

only open flap debridement

Group Type PLACEBO_COMPARATOR

open flap debridement

Intervention Type PROCEDURE

periodontal surgery technique

Test group

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

Group Type ACTIVE_COMPARATOR

open flap debridement and Hyaluronic Acid-Based Gel application

Intervention Type DRUG

Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent

open flap debridement

Intervention Type PROCEDURE

periodontal surgery technique

Interventions

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open flap debridement and Hyaluronic Acid-Based Gel application

Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent

Intervention Type DRUG

open flap debridement

periodontal surgery technique

Intervention Type PROCEDURE

Other Intervention Names

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Test group Control group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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Prof.Dr. Figen ÖNGÖZ DEDE

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ordu University

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Locations

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Ordu University

Ordu, Altınordu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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77158231

Identifier Type: -

Identifier Source: org_study_id

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