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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy

Intervention / Treatment
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* Procedure: Partial pulpotomy
* Procedure: Full Pulpotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partial Pulpotomy<br>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. | Procedure: Partial pulpotomy<br>* Partial pulp tissue amputation<br>|
| Active Comparator: Full Pulpotomy<br>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. | Procedure: Full Pulpotomy<br>* Full Pulpotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain level measured by visual analogy scale from 0-10 | scale from 0-10 | 48 hours | 
| Post operative pain level measured by a numerical scale from 0-10 | scale from 0-10 | 48 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irreversible pulpits, Pulpotomy, Outcome