COMPARATIVE EVALUATION OF RETINOL AUGMENTED INJECTABLE PLATELET RICH FIBRIN AND INJECTABLE PLATELET RICH FIBRIN ALONE IN PERIODONTAL REGENERATION USING MODIFIED MINIMALLY INVASIVE SURGICAL TECHNIQUE A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Clinical attachment level (CAL) gain in periodontal intrabony defects
研究概览
简要总结
This randomized clinical trial aims to compare the effectiveness of retinol-augmented injectable platelet-rich fibrin (i-PRF) with injectable platelet-rich fibrin (i-PRF) alone when used along with a modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.
A total of 26 systemically healthy patients with stage III grade B periodontitis will be randomly allocated into two groups. One group will receive retinol-augmented i-PRF with M-MIST, while the control group will receive i-PRF alone with M-MIST. Clinical parameters such as clinical attachment level and probing pocket depth will be evaluated at baseline, 3 months, and 6 months, along with radiographic assessment of bone fill at baseline and 6 months.
The study aims to assess whether the addition of retinol to i-PRF provides any additional benefit in periodontal regeneration compared to i-PRF alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •1.Males and females aged between 18 and 65 years.
- •two and three-walled intraosseous defects and probing depth more than or equal to 6mm and clinical attachment loss more than or equal to 4mm
- •intraosseous defect depth more than or equal to 3mm following professional mechanical plaque removal and full-mouth bleeding or plaque score less than or equal to 20 percent.
排除标准
- •Subjects with suprabony defects
- •Subjects with I-wall defects.
- •Subjects with grade II/III mobility.
- •Subjects with bleeding disorders.
- •Subjects with smoking habits
- •Pregnancy or breastfeeding at the time of study.
- •Subjects with any systemic illness known to influence the outcome of periodontal surgery.
结局指标
主要结局
Clinical attachment level (CAL) gain in periodontal intrabony defects
时间窗: baseline 3 months and 6 months
次要结局
- Probing pocket depth (PPD) reduction
研究者
Jayalakshmi L
AJ institute of dental sciences