Comparative Efficacy of Active Oxygen Gel Versus Chlorhexidine Gel as an Adjunct to Subgingival Instrumentation in the Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial With Biomarkers Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Clinical attachment level
研究概览
简要总结
This randomized controlled clinical trial will evaluate the effectiveness of locally delivered active oxygen gel and chlorhexidine gel as adjuncts to scaling and root planing in the treatment of stage II grade B periodontitis.Sixty participants will be randomly assigned to one of three parallel groups: SRP with placebo gel, SRP with active oxygen gel, or SRP with chlorhexidine gel. The study will evaluate changes in probing pocket depth, clinical attachment level, gingival index, plaque index, and gingival crevicular fluid tumor necrosis factor alpha levels at baseline and follow-up visits to compare the effects of the three treatment approaches.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-50 years.
- •Patients with stage II grade B periodontitis
- •Probing pocket. Depth less or equal to 5mm, CAL = 3 to 4mm in selected sites.
- •Good general health without systemic conditions affecting periodontal health.
排除标准
- •Pregnancy or lactating.
- •Allergy to chlorhexidine.
- •Patients under antibiotics or anti-inflammatory drugs within the past 3 months.
- •Previous periodontal therapy within the past 6 months.
研究组 & 干预措施
Group A - SRP plus placebo gel
Scaling and root planing followed by locally delivered placebo gel ( Methyl Cellulose Gel)
干预措施: Placebo gel (Methyle cellulose) (Drug)
Group B - SRP plus Active oxygen gel
Scaling and root planing followed by locally delivered active oxygen gel
干预措施: Active oxygen gel (Drug)
Group C - SRP plus chlorhexidine gel
Scaling and root planing followed by locally delivered chlorhexidine gel
干预措施: Chlorhexidine gel (Drug)
结局指标
主要结局
Clinical attachment level
时间窗: Baseline, 1,3, and 6 months
Clinical attachment level (CAL) will be measured in millimeters using UNC-15 periodontal probe from cementoenamel junction (CEJ) to the base of the pocket at baseline, 1, 3, and 6 months post-treatment.
Tumor necrosis factor alpha (TNF-alpha)
时间窗: Baseline, 1, and 3 months.
Tumor necrosis factor alpha levels in gingival crevicular fluid will be measured pg/ml using enzyme-linked immunosorbent assay (ELISA)
次要结局
- Probing pocket depth (PPD)(Baseline, 1, 3, and 6 months)
- Gingival index (GI)(Baseline, 1, 3, and 6 months.)
- Plaque index (PI)(Baseline, 1, 3, and 6 months.)
研究者
Sara Adam Abdalla Malik
Postgraduate Researcher, Department of Periodontology, Faculty of Dentistry, Kafrelsheikh University
Kafrelsheikh University