The Role of the Pre-operative Condition and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional root canal treatment, Full pulpotomy.
- Who it may be relevant to
- Registry conditions: Pulpitis - Irreversible. Basic parameters: 20 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Procedure Conventional root canal treatment
The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis. - Procedure Full pulpotomy
The patients will receive full pulpotomy as follows: -Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis in all canals, and apply the bioceramic material. The operator will seal the cavity with a glass ionomer restoration.
Primary outcome measures
- Percentage of Successful Cases [Time frame: After 1, 3, and 6 months.]
- Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure [Time frame: On the day of the procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Misr International University (MIU) — Cairo
- Misr International University — Cairo
Identifiers
NCT: NCT07340606 · MIU-IRB-2425-036