ROLE OF AMNIOTIC MEMBRANE AND PLATELET RICH FIBRIN IN BONE HEALING POST ENDODONTIC SURGERY: A COLOR DOPPLER SONOGRAPHY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1-Percentage reduction in the size of periapical lesion
研究概览
简要总结
The current study is a randomised, double blinded, parallel group, single center study. The study will be done in the Department of Endodontics and Department of Radiodiagnosis of KGMU, Lucknow. Primary objective is to evaluate the efficacy of freeze dried, gamma irradiated amniotic membrane(AM) in bone healing after periapical endodontic surgery and to compare it with autologous platelet rich fibrin membrane (PRF) that is one of the accepted standard treatment for regenerative procedures of oral cavity. Evaluation will be done using ultrasound and color doppler imaging technique.
Amniotic membrane will be availed from tisuue bank of Tata Memorial Hospital, Mumbai; while PRF will be made from patient’s own blood using a PRF centrifuge machine in the department itself.
The primary outcomes of the study are-
1)Percentage reduction in the size of the periapical lesion(surgical site) after bony curettage.
2)Percentage change in peak systolic velocity of blood, showing change in vascularity of the treated lesion.
Time points of evaluation are baseline, 1 month and 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Single rooted, anterior teeth.
- •Non-surgical re-treatment cases showing signs of failure like pain, swelling, sinus, pus discharge, etc.
- •Patients who are not on any systemic medication affecting periapical healing.
排除标准
- •Patients having insufficient motivation and capablility of reporting back for follow up visits to the clinics.
- •Patients with any systemic diseases like Diabetes Mellitus, Hypertension, Hepatitis, HIV, bone disorders etc.
- •Surgical retreatment cases.
- •Patients with malignant tumors or undergoing chemotherapy/radiotherapy.
- •Pregnant females.
- •Uncooperative patients.
- •Periodontally compromised teeth.
结局指标
主要结局
1-Percentage reduction in the size of periapical lesion
时间窗: 1 month after endodontic surgery
2-Percentage change in blood velocity of periapical lesions
时间窗: 1 month after endodontic surgery
次要结局
- 1-Percentage reduction in the size of periapical lesion(2-Percentage change in blood velocity of periapical lesions)