The Role of Wolters Pulpitis Classification, Apical Periodontitis, and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 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 severity of pulpal inflammation, carious pulp exposure, and the presence of apical periodontitis, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. It also aims to investigate the role of artificial intelligence-assisted diagnosis in predicting the prognosis of full pulpotomy.
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 digital radiographs will be taken, and radiographic caries depth will be assessed.
- The presence of pre-operative apical periodontitis will be recorded.
- An artificial intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure and apical periodontitis.
- The patients will be randomly allocated to receive either full pulpotomy or conventional root canal treatment.
- The cases will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. The accuracy of the AI software will be compared to the clinical findings of pulpal exposure after caries removal.
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, Investigator)
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 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.
研究组 & 干预措施
Root Canal Treatment
The patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.
干预措施: Conventional root canal treatment (Procedure)
Full Pulpotomy
The patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.
干预措施: Full pulpotomy (Procedure)
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 findings 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