The Effect of Prognostic Factors on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis
NCT ID: NCT06597487
Last Updated: 2025-07-25
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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COMPLETED
NA
58 participants
INTERVENTIONAL
2024-10-15
2025-07-01
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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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 from all canals, and apply the bioceramic material. The operator will seal the cavity with glass ionomer restoration.
Interventions
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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 from all canals, and apply the bioceramic material. The operator will seal the cavity with glass ionomer restoration.
Conventional root canal treatment
The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
Eligibility Criteria
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Inclusion Criteria
* Presence of bleeding pulp tissues 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 A Ghobashy, Prof. Dr.
Role: STUDY_DIRECTOR
Misr International University
Locations
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Misr International University
Cairo, , Egypt
Countries
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Other Identifiers
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MIU-IRB-2324-039
Identifier Type: -
Identifier Source: org_study_id
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