The Role of the Pre-operative Condition and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars
NCT ID: NCT07340606
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2026-01-17
2026-09-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Root Canal Treatment
The patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.
Conventional root canal treatment
The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
Full Pulpotomy
The patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.
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.
Interventions
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Conventional root canal treatment
The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
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.
Eligibility Criteria
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Inclusion Criteria
* Presence of bleeding from all canals.
* The tooth is not periodontally compromised.
Exclusion Criteria
* Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
* Molars with immature roots.
20 Years
45 Years
ALL
Yes
Sponsors
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Misr International University
OTHER
Responsible Party
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Mayand Amer Mohamed Yehia Amer
Principal Investigator
Principal Investigators
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Ahmed M Ghobashy, Prof. Dr.
Role: STUDY_DIRECTOR
Misr International University
Mayand A Amer, B.D.S.
Role: PRINCIPAL_INVESTIGATOR
Misr International University
Marwan S Ibrahim, B.D.S.
Role: PRINCIPAL_INVESTIGATOR
Misr International University
Locations
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Misr International University (MIU)
Cairo, , Egypt
Misr International University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Ahmed M. Ghobashy, Prof. Dr.
Role: primary
Other Identifiers
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MIU-IRB-2425-036
Identifier Type: -
Identifier Source: org_study_id
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