Periodontitis (Stage 3)
Conditions
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.
Interventions
DRUGopen flap debridement and Hyaluronic Acid-Based Gel application
Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent
PROCEDUREopen flap debridement
periodontal surgery technique
Sponsors
Ordu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | Baseline | to assess plaque accumulation |
| Gingival Index | Baseline | for evaluating gingival inflammation |
| Probing pocket depth | Baseline | for measuring disease severity |
| clinical attachment level | 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. |
| Bleeding on Probing | baseline | to assess disease activity |
| IL-6 | Baseline | IL-6 levels in gingival crevicular fluid (GCF) |
| IL-8 | baseline | IL-8 levels in gingival crevicular fluid (GCF) |
| IL-17A | baseline | IL-17A levels in gingival crevicular fluid (GCF) |
| IL-10 | baseline | IL-10 levels in gingival crevicular fluid (GCF) |
| Total antioxidant status | baseline | TAS levels in gingival crevicular fluid (GCF) |
| Total oxidant status | baseline | TOS levels in gingival crevicular fluid (GCF) |
Countries
Turkey (Türkiye)
Outcome results
None listed