Clinical trial NCT06842511: Effects of the Adjunctive Use of Hyaluronic Acid-based Gel in the Surgical Periodontal Treatment of Periodontitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Periodontitis (Stage 3)
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque Index
timeFrame: Baseline
measure: Plaque Index
timeFrame: Pre-surgery
measure: Plaque Index
timeFrame: post-surgery 1 month
measure: Plaque Index
timeFrame: post-surgery 6 months
measure: Gingival Index
timeFrame: Baseline
measure: Gingival Index
timeFrame: Pre-surgery
measure: Gingival Index
timeFrame: post-surgery 1 month
measure: Gingival Index
timeFrame: post-surgery 6 months
measure: Probing pocket depth
timeFrame: Baseline
measure: Probing pocket depth
timeFrame: pre-surgery
measure: Probing pocket depth
timeFrame: post-surgery 1 months
measure: Probing pocket depth
timeFrame: post-surgery 6 months
measure: clinical attachment level
timeFrame: Baseline
measure: clinical attachment level
timeFrame: pre-surgery
measure: clinical attachment level
timeFrame: post-surgery 1 months
measure: clinical attachment level
timeFrame: post-surgery 6 months
measure: Bleeding on Probing
timeFrame: baseline
measure: Bleeding on Probing
timeFrame: pre-surgery
measure: Bleeding on Probing
timeFrame: post-surgery 1 months
measure: Bleeding on Probing
timeFrame: post-surgery 6 months
measure: IL-6
timeFrame: Baseline
measure: IL-8
timeFrame: baseline
measure: IL-17A
timeFrame: baseline
measure: IL-10
timeFrame: baseline
measure: Total antioxidant status
timeFrame: baseline
measure: Total oxidant status
timeFrame: baseline
measure: IL-6
timeFrame: pre-surgery
measure: IL-8
timeFrame: pre-surgery
measure: IL-17A
timeFrame: pre-surgery
measure: IL-10
timeFrame: pre-surgery
measure: Total antioxidant status
timeFrame: pre-surgery
measure: Total oxidant status
timeFrame: pre-surgery
measure: IL-6
timeFrame: post-surgery 1 month
measure: IL-8
timeFrame: post-surgery 1 month
measure: IL-17A
timeFrame: post-surgery 1 month
measure: IL-10
timeFrame: post-surgery 1 month
measure: Total antioxidant status
timeFrame: post-surgery 1 month
measure: Total oxidant status
timeFrame: post-surgery 1 month
measure: IL-6
timeFrame: post-surgery 6 month
measure: IL-8
timeFrame: post-surgery 6 month
measure: IL-17A
timeFrame: post-surgery 6 month
measure: IL-10
timeFrame: post-surgery 6 month
measure: Total antioxidant status
timeFrame: post-surgery 6 month
measure: Total oxidant status
timeFrame: post-surgery 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
state: Altınordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Ordu University
role: PRINCIPAL_INVESTIGATOR
References: