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

NCT06597487 | Completed

• 1 other identifier: MIU-IRB-2324-039
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis - Irreversible

Keywords

irreversible pulpitis; full pulpotomy; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Percentage of Successful Cases

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

  After 1, 3, and 6 months

• Diagnostic accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure

  * 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.

  On the day of the procedure

Study Arms (2)

Root Canal Treatment

ACTIVE COMPARATOR

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.

Procedure: Conventional root canal treatment

Full Pulpotomy

EXPERIMENTAL

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.

Procedure: Full pulpotomy

Interventions

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.

Full Pulpotomy

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.

Root Canal Treatment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mature permanent molars with irreversible pulpitis.
• Presence of bleeding pulp tissues from all canals.
• The tooth is not periodontally compromised.

You may not qualify if:

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

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, Egypt

Location

Study Officials

• Ahmed A Ghobashy, Prof. Dr.

  Misr International University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

EG (1)