The Role of the Pre-operative Condition and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorMisr International University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Mature permanent molars with irreversible pulpitis.

Presence of bleeding from all canals.

The tooth is not periodontally compromised.

Disqualifiers

Non-vital teeth.

Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.

Molars with immature roots.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional root canal treatment

    Procedure/Surgery

    The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.

  • Full pulpotomy

    Procedure/Surgery

    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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Root Canal TreatmentActive comparator 1 intervention
Group B: Full PulpotomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Successful Cases

* It will be measured as a percentage. * It will be decided according to the clinical and radiographic criteria of success and failure.

Time frame
After 1, 3, and 6 months.
2

Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure

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.

Time frame
On the day of the procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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