Comparative evaluation of Platelet Rich Fibrin (PRF) and chorion membrane as a scaffold in apexogenesis using Cone beam computed tomography (CBCT)- A randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical ssessment of positive pulp response, abscence of mobility, pain , tenderness
研究概览
简要总结
This study is a randomized, double blind, parallel arm design comparing the effect of Platelet Rich Fibrin (PRF) and Chorion membrane as a scaffold in apexogenesis using cone beam computed tomography (CBCT) carried out in Tamil Nadu Government Dental College and Hospital among 20 patients of age group 13 to 30 years of both gender with immature necrotic teeth exhibiting radiographic evidence of open apex. The primary outcome being clinical evaluation of positive pulp response, absence of mobility, pain, tenderness to percussion and reduction of periodontal probing depth. Secondary outcome being radiographic evidence of increase in root length, dentin wall thickness and narrowing of canal space, root development and apical end closure at end of 3,6,9,12,15,18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with no systemic disease, Periodontally healthy individuals, Patients willing for voluntary participation and have signed the informed consent, Patents with good oral hygiene Patients with necrotic immature teeth exhibiting radiographic evidence of open apex without periapical pathology or periapical pathology (<_10mm).
排除标准
- •Patients who are allergic to Ciprofloxacin , Metronidazole or Minocycline, Patient with known systemic diseases, Teeth not conducive for rubber dam isolation, Grossly decayed or fractured teeth, Teeth with periapical radiolucency >10mm, Teeth with internal or External root resorption, Periodontally compromised teeth,Patients with bleeding disorders,Platelet count < 1,50,000/mm3, Pregnant women in view of requirements for radiographs.
结局指标
主要结局
Clinical ssessment of positive pulp response, abscence of mobility, pain , tenderness
时间窗: 3,6,9,12,15,18 months
to percussion and reduction of periodontal probing depth
时间窗: 3,6,9,12,15,18 months
次要结局
- Radiographic assessment of increase in root length , dentin wall thickness and narrowing of(canal space, root development and apical end closure)