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NCT Number: NCT07340606

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

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.

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Key information

Conditions

Pulpitis - Irreversible Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misr International University, Cairo, Egypt

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Root Canal Treatment

Procedure

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

Full Pulpotomy

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 in all canals, and apply the bioceramic material. The operator will seal the cavity with a glass ionomer restoration.

Primary outcomes

  1. Percentage of Successful Cases

    Time frame: After 1, 3, and 6 months.

    • It will be measured as a percentage.
    • It will be decided according to the clinical and radiographic criteria of success and failure.

  2. Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure

    Time frame: On the day of the procedure

    The artificial intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical findings of carious pulp exposure will be used as the gold standard).

    -The outcome will be reported as sensitivity and specificity.

Study contacts

Contact information is provided by the study sponsor or research team.

Mayand A Amer, B.D.S.

CONTACT

[email protected]

01062509703 ext. +02

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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