跳至主要内容
临床试验/CTRI/2025/01/078984
CTRI/2025/01/078984尚未招募4 期

Post Endodontic surgery bone healing comparison-Platelet Rich Fibrin and Bone Putty: A Randomized controlled trial

All India Institute of Medical Sciences, Jodhpur1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年1月29日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Extent of lesion will be calculated Supero-inferiorly, mesio-distally, bucco-lingually and assess the change in defect size and volume using CBCT volumetric analysis preoperatively and post operatively in one year of follow up

研究概览

简要总结

In cases of significant bony defects, regeneration of the missing periapical tissue is extremely difficult. Periapical surgery uses a variety of bone transplant and regenerative materials. Bone replacement materials should be biocompatible, noncarcinogenic and should act as a scaffold for the development of new bone and gradually resorb to make room for it. Bone putty is a biomaterial that shows promising results in bone regeneration and healing. Using this bone putty, few case reports have shown healing with the development of mature bone in large periapical lesions of endodontic origin with palatal perforations. The second-generation platelet concentrates known as platelet-rich fibrin (PRF) is a rich source of growth factors and can be used to effectively induce tissue regeneration and repair. Cone beam computed tomography (CBCT) is a 3D imaging modality that provides high resolution distortion free images of the bone and surrounding structures. ITK-SNAP is an open-source software for quantifying the healing progress. Thus, the present study aims to correlate and compare bone healing with CBCT volumetric analysis after endodontic surgery using Bone putty as compared to Platelet Rich Fibrin, in one year follow up. A total of 44 patients who meet the inclusion criteria will be enrolled for clinical trial and two different materials (Platelet Rich Fibrin and Bone Putty) will be used in the bony defects. Preoperative to one year post operative reduction in volume (mm3) will be calculated and the mean values obtained for both the groups will be statistically analyzed and evaluated for any significant difference.

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
16.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients over the age of 16 years regardless of the gender.
  • Patients with large periapical lesions of endodontic origin.
  • Patients planned for surgical intervention subsequent to conventional endodontics.

排除标准

  • Patients not planned for endodontic surgery.
  • All patients for medical reason who cannot undergo endodontic surgery because of systemic conditions
  • Patient denied to participate.

结局指标

主要结局

Extent of lesion will be calculated Supero-inferiorly, mesio-distally, bucco-lingually and assess the change in defect size and volume using CBCT volumetric analysis preoperatively and post operatively in one year of follow up

时间窗: Preoperatively and Post operatively (one year of follow up)

次要结局

  • Amount of radiographic(bone fill will be calculated)

研究者

发起方
All India Institute of Medical Sciences, Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr PRAVIN KUMAR

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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