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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Procedure: Conventional root canal treatment; Procedure: Full pulpotomy

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Misr International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Root Canal Treatment; 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; The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
Experimental: Full Pulpotomy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Misr International University
• Investigators: Study Director: Ahmed A Ghobashy, Prof. Dr., Misr International University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence; irreversible pulpitis; full pulpotomy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis
• Other Study ID Numbers: MIU-IRB-2324-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No