Comparative evaluation of the efficacy of subgingival application of i-PRF as adjunctive therapy to SRP in treatment of smoker versus non-smoker patients with Periodontitis: A split-mouth, randomized controlled clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in probing pocket depth (PPD)
研究概览
简要总结
Periodontitis is a chronic inflammatory disease that can lead to progressive destruction of periodontal tissues. Smoking is a major risk factor that negatively influences the outcome of periodontal therapy. Injectable platelet-rich fibrin (i-PRF), a second-generation platelet concentrate, has shown potential in promoting periodontal healing and regeneration. This randomized, split-mouth clinical trial aims to compare the efficacy of subgingival application of i-PRF as an adjunctive therapy to scaling and root planing (SRP) in smoker and non-smoker patients with periodontitis. Clinical parameters including probing pocket depth, clinical attachment level, and bleeding on probing will be evaluated as primary outcomes, while plaque index, gingival index, and gingival bleeding index will be assessed as secondary outcomes over a follow-up period of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •included greater than or equal to 20 teeth, greater than or equal to contralateral sites with probing depth 5 to 6 mm and CAL less than or equal to 5 mm, and absence of plaque-retentive factors.
排除标准
- •included systemic disease, recent periodontal therapy or antibiotics, pregnancy or lactation, or need for periodontal surgery.
结局指标
主要结局
Reduction in probing pocket depth (PPD)
时间窗: Baseline (prior to intervention) | 1 month | 3 months | 6 months
Gain in clinical attachment level (CAL)
时间窗: Baseline (prior to intervention) | 1 month | 3 months | 6 months
次要结局
- To assess changes in Plaque Index (Silness and Löe, 1964), Gingival Index (Löe and Silness, 1963), and Gingival Bleeding Index (Ainamo & Bay, 1975) in smokers and non-smokers with periodontitis.(Baseline (prior to intervention))
研究者
Dr Neha Singh
Sudha Rustagi College of Dental science and research
