Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

Study Overview
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Brief Summary
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Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.

Detailed Description
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The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain. The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration. Follow up for pain levels will be done during the first week. clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years. Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs. The 3 materials will be compared in terms of clinical and radiographic outcomes. demographic data of the three groups will be also compared predictive factors of success will be also analyzed tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.

Official Title
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Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial

Conditions
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Carious Teeth

Intervention / Treatment
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* Procedure: MTA pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mature permanent tooth with carious lesion exposing the pulp, Positive response to cold test Clinical Diagnosis of reversible or irreversible pulpitis Restorable tooth by direct restoration or crown Healthy patient Exclusion Criteria: Non vital teeth Teeth without pulp exposure Inability to achieve hemostasis within 10 min after pulpotomy Non restorable teeth or teeth that require post and core restoration

Ages Eligible for Study
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Minimum Age: 16 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MTA pulpotomy<br>Tooth will receive MTA & resin composite restoration | Procedure: MTA pulpotomy<br>* Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration<br>* Other names: Biodentine pulpotomy and Bioceramic pulpotomy;|
| Active Comparator: Biodentine pulpotomy<br>Tooth will receive Biodentine & resin composite restoration | Procedure: MTA pulpotomy<br>* Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration<br>* Other names: Biodentine pulpotomy and Bioceramic pulpotomy;|
| Active Comparator: Bioceramic pulpotomy<br>Tooth will receive Bioceramic & resin composite restoration | Procedure: MTA pulpotomy<br>* Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration<br>* Other names: Biodentine pulpotomy and Bioceramic pulpotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of pain relief after treatment compared to preoperative pain level | Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic normalcy | Absence of pathology in the root and the bone surrounding the apex | 1 year and yearly up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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teeth, caries, pulpotomy, MTA, biodentine, bioceramic