Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Degree of pain relief after treatment compared to preoperative pain level
研究概览
简要总结
Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.
详细描述
- The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
- The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
- Follow up for pain levels will be done during the first week.
- clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
- Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
- The 3 materials will be compared in terms of clinical and radiographic outcomes.
- demographic data of the three groups will be also compared
- predictive factors of success will be also analyzed
- tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patient unaware of the material to be used, care provider will be given the material after performing full pulpotomy . Tooth crown will be masked during assessment of radiographs
入排标准
- 年龄范围
- 16 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 with carious lesion exposing the pulp,
- •Positive response to cold test
- •Clinical Diagnosis of reversible or irreversible pulpitis
- •Restorable tooth by direct restoration or crown
- •Healthy patient
排除标准
- •Non vital teeth
- •Teeth without pulp exposure
- •Inability to achieve hemostasis within 10 min after pulpotomy
- •Non restorable teeth or teeth that require post and core restoration
结局指标
主要结局
Degree of pain relief after treatment compared to preoperative pain level
时间窗: 1 week
Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.
次要结局
- Radiographic normalcy(1 year and yearly up to 5 years)