NCT05279820

Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits

Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jordan University of Science and Technology · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up. The study design will be a double blind randomized clinical trial.

Detailed description

Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm. Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded. Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken. Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively. Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests

Conditions

• Carious Exposure of Pulp
• Irreversible Pulpitis
• Pulpotomy

Interventions

Type	Name	Description
PROCEDURE	Partial pulpotomy	Partial pulp tissue amputation
PROCEDURE	Full Pulpotomy	Full Pulpotomy

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-01-01
• Completion: 2024-01-01
• First posted: 2022-03-15
• Last updated: 2022-03-15

Locations

1 site across 1 country: Jordan