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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III Grade B or C periodotitis
- •over 18 years old
- •signed the informed consent
排除标准
- •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
研究组 & 干预措施
Control group
only open flap debridement
干预措施: open flap debridement (Procedure)
Test group
open flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel
干预措施: open flap debridement and Hyaluronic Acid-Based Gel application (Drug)
Test group
open flap debridement + adjunctive use of 0.8% hyaluronic acid-based gel
干预措施: open flap debridement (Procedure)
结局指标
主要结局
Plaque Index
时间窗: post-surgery 6 months
to assess plaque accumulation
Gingival Index
时间窗: post-surgery 6 months
for evaluating gingival inflammation
Probing pocket depth
时间窗: post-surgery 6 months
for measuring disease severity
clinical attachment level
时间窗: 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.
IL-6
时间窗: post-surgery 6 month
IL-6 levels in gingival crevicular fluid (GCF)
Bleeding on Probing
时间窗: post-surgery 6 months
to assess disease activity
IL-8
时间窗: post-surgery 6 month
IL-8 levels in gingival crevicular fluid (GCF)
IL-17A
时间窗: post-surgery 6 month
IL-17A levels in gingival crevicular fluid (GCF)
IL-10
时间窗: post-surgery 6 month
IL-10 levels in gingival crevicular fluid (GCF)
Total antioxidant status
时间窗: post-surgery 6 month
TAS levels in gingival crevicular fluid (GCF)
Total oxidant status
时间窗: post-surgery 6 month
TOS levels in gingival crevicular fluid (GCF)
次要结局
未报告次要终点
研究者
Prof.Dr. Figen ÖNGÖZ DEDE
Clinical Professor
T.C. ORDU ÜNİVERSİTESİ