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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-07-01

Brief Summary

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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

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* 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.

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Conventional root canal treatment

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Full pulpotomy

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Conventional root canal treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Misr International University

OTHER

Sponsor Role lead

Responsible Party

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Mayand Amer Mohamed Yehia Amer

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Egypt

Other Identifiers

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MIU-IRB-2324-039

Identifier Type: -

Identifier Source: org_study_id

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