Influence of Wolters Classification of Pulpitis and the Radiographic Caries Depth Detected Using Artificial Intelligence on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage of Successful Cases
研究概览
简要总结
This study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis.
详细描述
- Patients with mature permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
- The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
- Pre-operative radiographs will be taken, and radiographic caries depth will be assessed.
- An Artificial Intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure. The diagnostic accuracy of the software will be evaluated by comparing its readings with clinical findings of pulp exposure after caries removal.
- The patients will be randomized to receive either full pulpotomy or conventional root canal treatment.
- The patients will be followed up for 1, 3 and 6 months to assess clinical and radiographic success.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mature permanent molars with irreversible pulpitis.
- •Presence of bleeding pulp tissues from all canals.
- •The tooth is not periodontally compromised.
排除标准
- •Non-vital teeth.
- •Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
- •Molars with immature roots.
结局指标
主要结局
Percentage of Successful Cases
时间窗: After 1, 3, and 6 months
* It will be measured as a percentage. * It will be decided according to the clinical and radiographic criteria of success and failure.
Diagnostic accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
时间窗: On the day of the procedure
* The Artificial Intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical finding of carious pulp exposure will be used as the gold standard). * The outcome will be reported as Sensitivity and Specificity.
次要结局
未报告次要终点
研究者
Mayand Amer Mohamed Yehia Amer
Principal Investigator
Misr International University