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临床试验/CTRI/2025/08/093827
CTRI/2025/08/093827尚未招募不适用

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.

Dr. Neha Singh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月7日最近更新:

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

发起方
Dr. Neha Singh
申办方类型
Other [Self Funded]
责任方
Principal Investigator
主要研究者

Dr Neha Singh

Sudha Rustagi College of Dental science and research

研究点 (1)

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