A Comparison of Gingival Crevicular Fluid Interleukin-6 levels with and without adjunctive Injectable Platelet Rich Fibrin after Scaling and Root Planing in Chronic Periodontitis with Type II Diabetes – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Decrease in Gingival Crevicular Fluid after placement of injectable platelet rich fibrin in test site
研究概览
简要总结
The study will be conducted in OPDof Periodontology, Sri Venkateshwaraa Dental College. Subjects fulfilling theinclusion criteria will be included in the study after obtaining writteninformed consent. The sites will be randomized using computer generatedsequence. Allocation concealment by SNOSE. Both the patient andassessor will be blinded. To avoid inter individual variation, allinterventions will be done by the same operator and the outcome will beevaluated by the same assessor. Subgingival scaling and rootplaning will be done in both control and experimental site followed by placementof Injectable Platelet Rich Fibrin only in test site using blunt cannula. Periodontal pack will begiven on both the sites followed by postoperative instructions. Interleukin-6levels will be assessed at baseline and 1 month. Clinicalparameters will be assessed at baseline, 1 month and 3months.
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
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Blood glucose level (HbA1c: 6.5-7.5%) •Subjects with comparable bilateral periodontal defects associated with premolar and molar •Clinical attachment level ≥ 3mm •Probing Pocket Depth 4-6mm •Plaque index score ≤ 1.9 •No history of periodontal therapy for past 6 months.
排除标准
- •â€¢Current smokers and alcoholics •Pregnant & lactating mothers •Blood disorders •Platelet count < 150000 cells/µl •Systemic disease (other than diabetes), Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use, Anticonvulsants) •Teeth with poor periodontal prognosis.
- •â€¢The teeth with poor filling and poorly fitted restorations.
结局指标
主要结局
Decrease in Gingival Crevicular Fluid after placement of injectable platelet rich fibrin in test site
时间窗: At baseline, 1 month
次要结局
- Decrease in probing depth, Clinical attachment loss, gingival bleeding index score and plaque index score(At baseline, 1 month, 3 months)