Comparison Of Enamel Matrix Derivative and Injectable Platelet Rich Fibrin as an adjunct to Non-Surgical Periodontal Therapy: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Mean clinical attachment level
研究概览
简要总结
This study is a randomized, single blind, parallel group, single center trial comparing the efficacy of two different adjuncts with non-surgical periodontal therapy in 45 patients with periodontitis that will be conducted for one and a half yeas in a single center in India. The outcome measures are improved clinical (probing pocket depth, clinical attachment loss, plaque index, gingival index) , biochemical (Human Gingival crevicular Fluid (GCF) Alkaline Phosphatse levels) and radiologic parameters (bone fill)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Stage II/III periodontitis- CAL of 5-8 mm with PPD of 5-8 mm, Interdental vertical defects detected by radiovisiographs.
排除标准
- •Patients who are systemically compromised, Patients who are smokers, Pregnant and lactating women, Subjects who had undergone periodontal therapy in the past 3 months, Subjects who were under antibiotic therapy in the past 3 months, Patients with metabolic diseases related to bone, Subjects on drugs that might alter bone metabolism.
结局指标
主要结局
Mean clinical attachment level
时间窗: Baseline, 15th day, 60th day, 3rd month, 6th month
Mean probing pocket depth
时间窗: Baseline, 15th day, 60th day, 3rd month, 6th month
Mean gingival index
时间窗: Baseline, 15th day, 60th day, 3rd month, 6th month
Mean plaque index
时间窗: Baseline, 15th day, 60th day, 3rd month, 6th month
Mean bone fill
时间窗: Baseline, 15th day, 60th day, 3rd month, 6th month
Mean alkaline phosphatase level in gingival crevicular fluid
时间窗: Baseline, 15th day, 60th day, 3rd month, 6th month
次要结局
未报告次要终点
研究者
Dr Madhumitha S
Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry