Amniotic membrane as a therapeutic agent for pulpotomy in permanent molars: A Randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical success of pulpotomy.
研究概览
简要总结
The current study is a randomized, double-blinded, parallel-group, single-center study. The study will be done in the Department of Endodontics of KGMU, Lucknow. The primary objective is to evaluate the efficacy of freeze-dried, gamma-irradiated amniotic membrane(AM) in pulpotomy of carious teeth with irreversible pulpitis and to compare it with mineral trioxide aggregate(MTA) that is one of the accepted standard treatment for vital pulp procedures of the teeth. Evaluation will be done by calculating the clinical and radiographical success at 1,3 and 9 months after the procedure.
The amniotic membrane will be availed from the tissue bank of Tata Memorial Hospital, Mumbai. Pro Root MTA from Dentsply(Switzerland) will be the comparator.
The primary outcomes of the study are-
1)Clinical success percentage for both groups.(AM and MTA)
The secondary outcomes of the study are-
1)Radiographical success percentage of both groups.
Time points of evaluation are 1, 3, and 9 months after the procedure.
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 44.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the age 18-35 years who give written consent to participate in the study.
- •Permanent molars having pulp exposure due to deep caries.
排除标准
- •Immature teeth 2)Patients showing clinical signs and symptoms of abscess/fistula, tenderness on percussion, and mobility.
- •Teeth showing radiographic signs of periapical pathology, furcation pathology and/or resorption.
- •Non-vital teeth.
结局指标
主要结局
Clinical success of pulpotomy.
时间窗: 1, 3 and 9 months
Evaluated by absence of signs and symptoms such as pain, inflammation, abscess/sinus, mobility, and crown failure
时间窗: 1, 3 and 9 months
次要结局
- Radiographical success of pulpotomy.(Evaluated by evaluating for pathological internal or external resorption, presence of calcifications and integrity of lamina dura)