PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Percentage radiographic defect depth reduction
研究概览
简要总结
Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth.
排除标准
- •Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.
研究组 & 干预措施
Platelet rich fibrin + atorvastatin
In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD
干预措施: Platelet rich fibrin +Atorvastatin (Drug)
Open flap debridement
open flap debridement was followed by no grafting or regenerative intervention.
干预措施: open flap debridement (Procedure)
Platelet rich fibrin
In Platelet rich fibrin group PRF was inserted into the depth of the IBD.
干预措施: Platelet rich fibrin (Drug)
结局指标
主要结局
Percentage radiographic defect depth reduction
时间窗: 9 months from baseline
Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs
次要结局
- change in probing depth(9 months from baseline)
- change in relative attachment level(9 months from baseline)
- change in plaque levels(9 months from baseline)
- change in gingival bleeding(9 months from baseline)
- change in gingival margin levels(9 months from baseline)
研究者
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore