Injectable-platelet rich fibrin (i-prf) as an adjunct to open flap debridement (ofd) in the management of periodontal osseous defects not indicated for regenerative therapy :a randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Probing pocket depth reduction
研究概览
简要总结
Periodontitis is a chronic inflammatory disease that causes destruction of the tooth-attachment apparatus. The aim of regenerative periodontal therapy is to restore the structure and function of the periodontium. The objective of this prospective intervention trial is to assess the effectiveness of adjunctive i PRF application along with open flap debridement in the treatment of periodontal osseous defects not indicated for regenerative therapy. Otherwise healthy adults with moderate to severe periodontitis who satisfy the inclusion and exclusion criteria will be randomised to test and control group. Baseline clinical parameters will be compared with post treatment periodontal parameters 6months after the therapy. Conclusions will be drawn based on results. The aim of this interventional clinical trial is to assess the clinical effectiveness of i-PRF in improving healing outcomes in horizontal defects by comparing it with conventional open flap debridement. This study is such an attempt whereby an inexpensive material which do not cause any allergic reaction can be used for treatment of horizontal bone defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults above 18years diagnosed with periodontitis (according to AAP,2017 classification) with residual probing pocket depth (PPD) ≥ 5 mm after step 1 and 2 therapy (non surgical phase) in at least two adjacent interproximal sites in either of the jaws 2) Systemically healthy subjects 3) Deep pockets associated with horizontal bone defects that are not indicated for regenerative therapy 4) Full Mouth Bleeding Score ≤ 30 % & Full Mouth Plaque Score ≤ 20%.
排除标准
- •Current tobacco users 2) Subjects taking medications affecting the periodontium (Bisphosphonates ,Calcium channel blockers ,cyclosporine ,phenytoin, steroids) 3) Pregnancy or lactation 4) Antibiotic medication in the last 3 months 5) Grade II/III furcation involvement 6) Infra bony defects that are indicated for resective or regenerative therapy.
结局指标
主要结局
Probing pocket depth reduction
时间窗: 6 months
次要结局
- 1)Clinical attachment gain(2)Gingival recession)