Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- Postoperative pain after 6 hours postoperatively
研究概览
简要总结
The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.
详细描述
- Patients will be clinically and radiographically examined and their eligibility will be assessed.
- Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA).
- After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA
- The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken.
- The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times.
- The patients will be recalled after 6 and 12 months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The study will be participant-blind where the participant will not know the intervention done.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aging between 18-40 years old
- •Patients with symptomatic irreversible pulpitis.
- •Radiographically: Absence or slight widening in periodontal ligament space.
- •Systemically- healthy patients (ASA I or II).
- •Patients who agree to attend for recall appointments and provide written consent.
排除标准
- •Severe marginal periodontitis.
- •Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.
- •Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.
研究组 & 干预措施
Mineral Trioxide Aggregate (MTA)
干预措施: MTA Pulpotomy. (Procedure)
Biodentine
干预措施: Biodentine Pulpotomy (Procedure)
结局指标
主要结局
Postoperative pain after 6 hours postoperatively
时间窗: 6 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"
Postoperative pain after 12 hours postoperatively
时间窗: 12 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"
Postoperative pain after 24 hours postoperatively
时间窗: 24 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"
次要结局
- Overall (clinical and radiographic) success after 6 months postoperatively.(6 months postoperatively)
- Overall (clinical and radiographic) success after 12 months postoperatively.(12 months postoperatively)
研究者
Youssef Andraws
Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University
Cairo University