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

Not Applicable

• Conditions: Carious Exposure of Pulp; Pulpotomy; Irreversible Pulpitis
• Interventions: Procedure: Partial pulpotomy; Procedure: Full Pulpotomy

• Registration Number: NCT05279820
• Lead Sponsor: Jordan University of Science and Technology

Brief 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

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-11-28
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15
• Primary Completion: 2023-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Mature permanent tooth
• Deep caries extending more than two thirds of dentine or exposing the pulp
• Tooth responds positively to cold test
• Clinical symptoms of irreversible pulpits
• Tooth is restorable and can be restored with coronal restoration
• Bleeding normally is confirmed after pulp exposure
• hemostasis could be achieved within 8 minutes

Exclusion Criteria

• Non restorable teeth
• necrotic teeth
• hemostasis could not be achieved within 8 minutes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial Pulpotomy	Partial pulpotomy	After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.
Full Pulpotomy	Full Pulpotomy	After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.

Primary Outcome Measures

Name	Time	Method
Post operative pain level measured by visual analogy scale from 0-10	48 hours	scale from 0-10
Post operative pain level measured by a numerical scale from 0-10	48 hours	scale from 0-10

Secondary Outcome Measures

Name	Time	Method
Clinical success as measured by clinical examination	6, 12, 24 months	The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination
Radiographic success as evaluated by periapical x-rays	6, 12, 24 months	There should be no evidence of bone resorption or root resorption on the x-ray

Trial Locations

Locations (1)

Jordan University of science and technology; 🇯🇴 Irbid, Jordan