Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars

Study Overview
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Brief Summary
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The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

Detailed Description
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Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department. A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University. Subjects will be assigned randomly into two different treatment groups as follows: MTA Group (1): Group 1(A): MTA Direct Pulp Capping. (n=25) Group 1 (B): MTA Partial Pulpotomy. (n=25) Group 1 (C): MTA Complete Pulpotomy. (n=25) BiodentineTM Group (2): Group 2(A): BiodentineTM Direct Pulp Capping. (n=25) Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25) Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)

Official Title
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Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars

Conditions
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Pulp Disease, Dental

Intervention / Treatment
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* Procedure: Direct Pulp Capping
* Procedure: Partial Pulpotomy
* Procedure: Pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal. Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess. Exclusion Criteria: Children who are extremely uncooperative and difficult to manage. Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN). Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct Pulp Capping with Biodentine<br>Direct Pulp Capping with Biodentine | Procedure: Direct Pulp Capping<br>* Direct Pulp Capping<br>|
| Experimental: Partial Pulpotomy with Biodentine<br>Partial Pulpotomy with Biodentine | Procedure: Partial Pulpotomy<br>* Partial Pulpotomy<br>|
| Experimental: Pulpotomy with Biodentine<br>Pulpotomy with Biodentine | Procedure: Pulpotomy<br>* Pulpotomy<br>|
| Experimental: Direct Pulp Capping with MTA<br>Direct Pulp Capping with MTA | Procedure: Direct Pulp Capping<br>* Direct Pulp Capping<br>|
| Experimental: Partial Pulpotomy with MTA<br>Partial Pulpotomy with MTA | Procedure: Partial Pulpotomy<br>* Partial Pulpotomy<br>|
| Experimental: Pulpotomy with MTA<br>Pulpotomy with MTA | Procedure: Pulpotomy<br>* Pulpotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars. | Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct pulp capping, Partial Pulpotomy, and Pulpotomy