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The Effect of Prognostic Factors on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06597487
Enrollment
58
Registered
2024-09-19
Start date
2024-10-15
Completion date
2025-07-01
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

irreversible pulpitis, full pulpotomy, artificial intelligence

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.

Interventions

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 from all canals, and apply the bioceramic material. The operator will seal the cavity with glass ionomer restoration.

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

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Successful CasesAfter 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 exposureOn 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026