CTRI/2020/10/028640尚未招募3 期
Partial versus full pulpotomy in the treatment of teeth with signs and symptoms indicative of irreversible pulpitis and the predictive value of pulpal biomarkers in determining outcome- A randomized controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- A composite measure, which requires absence of pain, absence of apical periodontitis and absence of internal root resorption to be confirmed by history, clinical examination and radiographic assessment at 1 year.
研究概览
简要总结
In this project, partial pulpotomy versus full pulpotomy will be compared for their clinical success. Post operative pain level will be evaluated at day 3 and 7 after the pulpotomy treatment. MMP 9 and IL 6 will be correlated with the failed cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •deep or extremely deep carious lesion radiographically on posterior teeth reaching close to the pulp (inner quarter of dentine i.e. >75%) and signs and symptoms indicative of irreversible pulpitis.
排除标准
- •Lack of availability for follow up (e.g. moving away), periodontal probing > 5 mm on tooth in question, mild symptoms indicative or reversible pulpitis, bleeding cannot be arrested after 10 minutes.
结局指标
主要结局
A composite measure, which requires absence of pain, absence of apical periodontitis and absence of internal root resorption to be confirmed by history, clinical examination and radiographic assessment at 1 year.
时间窗: 1 year
次要结局
- Absence of pain (3 & 7 days post-operatively), structural integrity of tooth, no further interventions during 12 month follow up period, no adverse events. MMP9 and IL 6 levels to be correlated with failed cases.
研究者
研究点 (1)
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