Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

Study Overview
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Brief Summary
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The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.

Detailed Description
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Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA). After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken. The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times. The patients will be recalled after 6 and 12 months post-operatively.

Official Title
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Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Procedure: MTA Pulpotomy.
* Procedure: Biodentine Pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aging between 18-40 years old Patients with symptomatic irreversible pulpitis. Radiographically: Absence or slight widening in periodontal ligament space. Systemically- healthy patients (ASA I or II). Patients who agree to attend for recall appointments and provide written consent. Exclusion Criteria: Severe marginal periodontitis. Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula. Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mineral Trioxide Aggregate (MTA)<br> | Procedure: MTA Pulpotomy.<br>* Pulpotomy using MTA.<br>|
| Experimental: Biodentine<br> | Procedure: Biodentine Pulpotomy<br>* Pulpotomy using Biodentine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain after 6 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents no pain 1- 3 readings represent mild pain 4- 6 readings represent moderate pain 7- 10 readings represent severe pain | 6 hours postoperatively | 
| Postoperative pain after 12 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents no pain 1- 3 readings represent mild pain 4- 6 readings represent moderate pain 7- 10 readings represent severe pain | 12 hours postoperatively | 
| Postoperative pain after 24 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents no pain 1- 3 readings represent mild pain 4- 6 readings represent moderate pain 7- 10 readings represent severe pain | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall (clinical and radiographic) success after 6 months postoperatively. | Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure. | 6 months postoperatively | 
| Overall (clinical and radiographic) success after 12 months postoperatively. | Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure. | 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success