Efficacy of injectable platelet rich fibrin with xenograft compared to xenograft alone in the treatment of two or three wall intrabony defect in patients with stage 3 periodontitis a randomized controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinical attachment level in mm
研究概览
简要总结
This study titled “Efficacy of Injectable Platelet Rich Fibrin (I-PRF) with Xenograft Compared to Xenograft Alone in the Treatment of Two or Three-Wall Intrabony Defects in Stage III Periodontitis – A Randomized Controlled Trial” is being conducted at the Government Dental College. The study aims to evaluate whether the addition of injectable platelet-rich fibrin (I-PRF) to xenograft provides superior clinical and radiographic outcomes compared to xenograft alone in patients diagnosed with Stage III periodontitis presenting with two- or three-wall intrabony defects. A total of 42 patients will be recruited and randomly allocated into two groups: Group A will receive xenograft combined with I-PRF, while Group B will receive xenograft alone. All participants will undergo initial phase I therapy followed by open flap debridement and placement of the respective graft material. The primary outcome measure is change in Clinical Attachment Level (CAL) at 4 months, assessed using a UNC-15 probe. Secondary outcomes include probing pocket depth, gingival recession, linear bone growth assessed radiographically using RVG, and patient satisfaction measured with VAS score. This two-arm, parallel, open-label randomized controlled trial will have follow-ups at 1 and 4 months. Data will be statistically analyzed using appropriate tests with significance set at p < 0.05. Ethical approval will be obtained from the Institutional Ethics Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18 years and above who is willing to participate .
- •Patient diagnosed with stage III periodontitis with clinical attachment level greater than or equal to 5mm and probing Depth greater than or equal to 6mm
- •Two or three walled intra bony defect measuring greater than or equal to 3mm radiographically using RVG.
排除标准
- •Uncontrolled systemic diseases.
- •History of periodontal surgery in the site within 6 months.
- •Current smoker or using tobacco related product.
- •Pregnant and lactating mother.
- •Patients on medications affecting bone metabolism.
结局指标
主要结局
Clinical attachment level in mm
时间窗: Base line ,4 month
次要结局
- Periodontal probing depth in mm
- Gingival recession in mm(Base line ,4 month)
- Linear bone growth in mm(Base line ,4 month)
- Patient satisfaction assessed using VAS Score(4 Month)
研究者
ANAGHA T
Goverment dental college Thiruvananthapuram
