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NCT Number: NCT06597487

The Effect of Prognostic Factors on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misr International University

Cairo, Egypt

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 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.

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 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.

Treatment and study plan

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

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.

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 finding of carious pulp exposure will be used as the gold standard).
    • The outcome will be reported as Sensitivity and Specificity.

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

Influence of Wolters Classification of Pulpitis and the Radiographic Caries Depth Detected Using Artificial Intelligence on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 25, 2025

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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