Actively Recruiting

Phase Not Applicable
Age: 20Years - 45Years
All Genders
Healthy Volunteers
ID07340606

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

Led by Misr International University · Updated on 2026-01-21

58

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how certain factors like the severity of pulpal inflammation, carious pulp exposure, and apical periodontitis affect the success of full pulpotomy in mature permanent molars diagnosed with irreversible pulpitis. The study also explores how artificial intelligence (AI) can assist in predicting the treatment outcome using pre-operative X-rays. This is a randomized controlled trial conducted by Misr International University to compare treatments and diagnostic methods. Participants will be randomly assigned to receive either full pulpotomy or conventional root canal treatment, the standard care for irreversible pulpitis. Full pulpotomy involves removing caries, preparing the access cavity, achieving hemostasis, applying bioceramic material, and sealing the cavity with a glass ionomer restoration. Both groups will be monitored with clinical and radiographic evaluations at 1, 3, and 6 months after treatment. The AI software will analyze pre-operative X-rays to detect carious pulp exposure and apical periodontitis, and its diagnostic accuracy will be compared to clinical findings. During the study, patients will have pre-operative assessments including pulp status classification and digital radiographs to evaluate caries depth and apical periodontitis. Follow-up visits at 1, 3, and 6 months will assess the percentage of successful cases based on clinical and radiographic criteria. The AI's sensitivity and specificity in detecting pulp exposure will also be measured on the day of the procedure. This study lasts at least 6 months after treatment and includes safety monitoring through regular follow-ups.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Mature permanent molars with irreversible pulpitis
  • Presence of bleeding from all canals
  • The tooth is not periodontally compromised
Not Eligible

You will not qualify if you...

  • Non-vital teeth
  • Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent
  • Molars with immature roots

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment visit

Participants receive either full pulpotomy or conventional root canal treatment for irreversible pulpitis in mature permanent molars.

1 treatment visit (in-person)

Follow-up

Duration - 6 months

Participants are followed up to assess clinical and radiographic success after treatment.

Visits at 1, 3, and 6 months post-treatment

Trial Site Locations

Total: 2 locations

1

Misr International University (MIU)

Cairo, Egypt

Actively Recruiting

2

Misr International University

Cairo, Egypt

Actively Recruiting

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Research Team

M

Mayand A Amer, B.D.S.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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