Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Post operative pain level measured by visual analogy scale from 0-10
研究概览
简要总结
This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.
The study design will be a double blind randomized clinical trial.
详细描述
Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis
Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.
Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.
Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.
Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years 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
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will not be informed whether the treatment performed was partial or full pulpotomy the outcome assessor will be blinded to the type of treatment performed, and evaluation of the radiographs will include masking the crown so that the procedure cannot be identified.
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mature permanent tooth
- •Deep caries extending more than two thirds of dentine or exposing the pulp
- •Tooth responds positively to cold test
- •Clinical symptoms of irreversible pulpits
- •Tooth is restorable and can be restored with coronal restoration
- •Bleeding normally is confirmed after pulp exposure
- •hemostasis could be achieved within 8 minutes
排除标准
- •Non restorable teeth
- •necrotic teeth
- •hemostasis could not be achieved within 8 minutes
研究组 & 干预措施
Partial Pulpotomy
After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.
干预措施: Partial pulpotomy (Procedure)
Full Pulpotomy
After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.
干预措施: Full Pulpotomy (Procedure)
结局指标
主要结局
Post operative pain level measured by visual analogy scale from 0-10
时间窗: 48 hours
scale from 0-10
Post operative pain level measured by a numerical scale from 0-10
时间窗: 48 hours
scale from 0-10
次要结局
- Clinical success as measured by clinical examination(6, 12, 24 months)
- Radiographic success as evaluated by periapical x-rays(6, 12, 24 months)