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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07340606
Enrollment
58
Registered
2026-01-14
Start date
2026-01-17
Completion date
2026-09-01
Last updated
2026-01-21

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, apical periodontitis

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.

Interventions

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

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.

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
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.

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 procedureThe 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.

Countries

Egypt

Contacts

CONTACTMayand A Amer, B.D.S.
mayand.amer@miuegypt.edu.eg01062509703
STUDY_DIRECTORAhmed M Ghobashy, Prof. Dr.

Misr International University

PRINCIPAL_INVESTIGATORMayand A Amer, B.D.S.

Misr International University

PRINCIPAL_INVESTIGATORMarwan S Ibrahim, B.D.S.

Misr International University

Outcome results

None listed

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