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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

M

Misr International University

Status

Enrolling

Conditions

Pulpitis - Irreversible

Treatments

Procedure: Full pulpotomy
Procedure: Conventional root canal treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT07340606
MIU-IRB-2425-036

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups

Root Canal Treatment
Active Comparator group
Description:
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.
Treatment:
Procedure: Conventional root canal treatment
Full Pulpotomy
Experimental group
Description:
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.
Treatment:
Procedure: Full pulpotomy

Trial contacts and locations

2

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Central trial contact

Mayand A Amer, B.D.S.

Data sourced from clinicaltrials.gov

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