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

Jordan University of Science and Technology

Status: Unknown

Conditions: Carious Exposure of Pulp; Irreversible Pulpitis; Pulpotomy

Treatments: Procedure: Full Pulpotomy; Procedure: Partial pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05279820

329/2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Partial Pulpotomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Partial pulpotomy

Full Pulpotomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Full Pulpotomy