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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Percentage of Successful Cases
Overview
Brief Summary
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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
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 pulp tissues 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.
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 finding 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