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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 58
- Primary Endpoint
- Percentage of Successful Cases
Overview
Brief Summary
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.
Detailed Description
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mature permanent molars with irreversible pulpitis.
- •Presence of bleeding from all canals.
- •The tooth is not periodontally compromised.
Exclusion Criteria
- •Non-vital teeth.
- •Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
- •Molars with immature roots.
Arms & Interventions
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.
Intervention: 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.
Intervention: Full pulpotomy (Procedure)
Outcomes
Primary Outcomes
Percentage of Successful Cases
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mayand Amer Mohamed Yehia Amer
Principal Investigator
Misr International University