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

February 21, 2025 updated by: Prof.Dr. Figen ÖNGÖZ DEDE, T.C. ORDU ÜNİVERSİTESİ

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altınordu
      • Ordu, Altınordu, Turkey, 52100
        • Ordu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
only open flap debridement
Procedure: open flap debridement
periodontal surgery technique
Other Names:
  • Control group
Active Comparator: Test group
open flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel
Procedure: open flap debridement
periodontal surgery technique
Other Names:
  • Control group
Drug: open flap debridement and Hyaluronic Acid-Based Gel application
Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent
Other Names:
  • Test group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: Baseline
to assess plaque accumulation
Baseline
Plaque Index
Time Frame: Pre-surgery
to assess plaque accumulation
Pre-surgery
Plaque Index
Time Frame: post-surgery 1 month
to assess plaque accumulation
post-surgery 1 month
Plaque Index
Time Frame: post-surgery 6 months
to assess plaque accumulation
post-surgery 6 months
Gingival Index
Time Frame: Baseline
for evaluating gingival inflammation
Baseline
Gingival Index
Time Frame: Pre-surgery
for evaluating gingival inflammation
Pre-surgery
Gingival Index
Time Frame: post-surgery 1 month
for evaluating gingival inflammation
post-surgery 1 month
Gingival Index
Time Frame: post-surgery 6 months
for evaluating gingival inflammation
post-surgery 6 months
Probing pocket depth
Time Frame: Baseline
for measuring disease severity
Baseline
Probing pocket depth
Time Frame: pre-surgery
for measuring disease severity
pre-surgery
Probing pocket depth
Time Frame: post-surgery 1 months
for measuring disease severity
post-surgery 1 months
Probing pocket depth
Time Frame: post-surgery 6 months
for measuring disease severity
post-surgery 6 months
clinical attachment level
Time Frame: Baseline
Clinical 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.
Baseline
clinical attachment level
Time Frame: pre-surgery
Clinical 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.
pre-surgery
clinical attachment level
Time Frame: post-surgery 1 months
Clinical 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.
post-surgery 1 months
clinical attachment level
Time Frame: post-surgery 6 months
Clinical 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.
post-surgery 6 months
Bleeding on Probing
Time Frame: baseline
to assess disease activity
baseline
Bleeding on Probing
Time Frame: pre-surgery
to assess disease activity
pre-surgery
Bleeding on Probing
Time Frame: post-surgery 1 months
to assess disease activity
post-surgery 1 months
Bleeding on Probing
Time Frame: post-surgery 6 months
to assess disease activity
post-surgery 6 months
IL-6
Time Frame: Baseline
IL-6 levels in gingival crevicular fluid (GCF)
Baseline
IL-8
Time Frame: baseline
IL-8 levels in gingival crevicular fluid (GCF)
baseline
IL-17A
Time Frame: baseline
IL-17A levels in gingival crevicular fluid (GCF)
baseline
IL-10
Time Frame: baseline
IL-10 levels in gingival crevicular fluid (GCF)
baseline
Total antioxidant status
Time Frame: baseline
TAS levels in gingival crevicular fluid (GCF)
baseline
Total oxidant status
Time Frame: baseline
TOS levels in gingival crevicular fluid (GCF)
baseline
IL-6
Time Frame: pre-surgery
IL-6 levels in gingival crevicular fluid (GCF)
pre-surgery
IL-8
Time Frame: pre-surgery
IL-8 levels in gingival crevicular fluid (GCF)
pre-surgery
IL-17A
Time Frame: pre-surgery
IL-17A levels in gingival crevicular fluid (GCF)
pre-surgery
IL-10
Time Frame: pre-surgery
IL-10 levels in gingival crevicular fluid (GCF)
pre-surgery
Total antioxidant status
Time Frame: pre-surgery
TAS levels in gingival crevicular fluid (GCF)
pre-surgery
Total oxidant status
Time Frame: pre-surgery
TOS levels in gingival crevicular fluid (GCF)
pre-surgery
IL-6
Time Frame: post-surgery 1 month
IL-6 levels in gingival crevicular fluid (GCF)
post-surgery 1 month
IL-8
Time Frame: post-surgery 1 month
IL-8 levels in gingival crevicular fluid (GCF)
post-surgery 1 month
IL-17A
Time Frame: post-surgery 1 month
IL-17A levels in gingival crevicular fluid (GCF)
post-surgery 1 month
IL-10
Time Frame: post-surgery 1 month
IL-10 levels in gingival crevicular fluid (GCF)
post-surgery 1 month
Total antioxidant status
Time Frame: post-surgery 1 month
TAS levels in gingival crevicular fluid (GCF)
post-surgery 1 month
Total oxidant status
Time Frame: post-surgery 1 month
TOS levels in gingival crevicular fluid (GCF)
post-surgery 1 month
IL-6
Time Frame: post-surgery 6 month
IL-6 levels in gingival crevicular fluid (GCF)
post-surgery 6 month
IL-8
Time Frame: post-surgery 6 month
IL-8 levels in gingival crevicular fluid (GCF)
post-surgery 6 month
IL-17A
Time Frame: post-surgery 6 month
IL-17A levels in gingival crevicular fluid (GCF)
post-surgery 6 month
IL-10
Time Frame: post-surgery 6 month
IL-10 levels in gingival crevicular fluid (GCF)
post-surgery 6 month
Total antioxidant status
Time Frame: post-surgery 6 month
TAS levels in gingival crevicular fluid (GCF)
post-surgery 6 month
Total oxidant status
Time Frame: post-surgery 6 month
TOS levels in gingival crevicular fluid (GCF)
post-surgery 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Investigators

  • Principal Investigator: Ordu University, T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77158231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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