CTRI/2021/06/034280已完成不适用
Clinical evaluation of the combined efficacy of scaling and root planing (SRP) and injectable platelet rich fibrin (i-PRF) in the non-surgical periodontal therapy of Stage III and Grade C periodontitis patients having Type 2 Diabetes mellitus. -A Randomized Controlled Trial
Shunmuga Prasanth D1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年6月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To evaluate the changes in the:
研究概览
简要总结
Subjects with Diabetes mellitus are prone to have more periodontal destruction than when compared to healthy individuals. uncontrolled Diabetes mellitus subjects respond poorly to the nonsurgical periodontal therapy alone in management of periodontal pockets. Hence, in this study we would like be clinically evaluate the adjunctive benefits of injectable platelet rich fibrin (i-PRF) along with scaling and root planing in periodontitis subjects with type 2 Diabetes mellitus(HbA1c>7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type 2 Diabetes mellitus subjects with the glycaemic status having HbA1c ≥ 7 2.Subjects on oral medication for the management of Diabetes mellitus.
- •3.Subject with moderate periodontal disease with the case definition, StageIII and Grade C periodontitis, according to EFP-AAP periodontal disease classification
- •i.e., Moderate periodontal destruction is defined as sites having ≥ 5mm probing pocket depth with attachment loss.
- •4.Moderate periodontal destruction at least, in 2 interproximal sites in each mandibular quadrant.
- •5.Minimum presence of 4 permanent teeth per mandibular quadrant (excluding 3rd molars).
排除标准
- •1.Sites with pseudo pockets / advanced periodontal destruction with mobility and Grade IV furcation involvement 2.Periodontal therapy within last 6 months 3.Previous history of intake of antibiotics over last 6 months 4.Systemic condition / disease other than Type II DM, having influence on course and treatment outcomes of periodontal disease.
- •5.Screening for the infectious disease will be done and the subjects with infectious diseases will be excluded.
- •6.Individuals with known platelet disorders 7.Smokers.
结局指标
主要结局
To evaluate the changes in the:
时间窗: Baseline | 3Months | 6Months
Clinical attachment level (CAL)
时间窗: Baseline | 3Months | 6Months
before and after therapy within and between the groups.
时间窗: Baseline | 3Months | 6Months
次要结局
- To evaluate the changes in the(1.Probing pocket depth (PPD))
研究者
研究点 (1)
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