跳至主要内容
临床试验/CTRI/2026/03/106271
CTRI/2026/03/106271尚未招募2/3 期

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

Dr Anagha T1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年4月10日最近更新:
适应症
相关药物

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

发起方
Dr Anagha T
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

ANAGHA T

Goverment dental college Thiruvananthapuram

研究点 (1)

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