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

Not Applicable

Active, not recruiting

• Conditions: Pulpitis - Irreversible
• Interventions: Procedure: Conventional root canal treatment; Procedure: Full pulpotomy

• Registration Number: NCT06597487
• Lead Sponsor: Misr International University

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.

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 Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2024-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Root Canal Treatment	Conventional 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.
Full Pulpotomy	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Successful Cases	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.
Diagnostic accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure	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.

Trial Locations

Locations (1)

Misr International University; 🇪🇬 Cairo, Egypt