Comparison of The Success Rates of Four Different Pulpotomy Techniques

Study Overview
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Brief Summary
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This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

Official Title
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Comparison of The Success Rates of Four Different Pulpotomy Techniques

Conditions
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Extensive Decay in Primary Molars

Intervention / Treatment
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* Drug: Biodentine
* Drug: ProRoot (Aggregate)
* Drug: MTA Plus
* Drug: Ferric Sulfate 20 % Dental Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable. Exclusion Criteria: The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 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: Split-mouth study design was used
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodentine<br>Biodentine pulpotomy agent | Drug: Biodentine<br> <br> * Other names: 77509635;|
| Experimental: ProRoot MTA<br>ProRoot MTA pulpotomy agent | Drug: ProRoot (Aggregate)<br> <br> * Other names: 75896452;|
| Experimental: MTA Plus<br>MTA Plus pulpotomy agent | Drug: MTA Plus<br> <br> * Other names: 85303191;|
| Active Comparator: Ferric Sulfate 20% Dental Gel<br>Ferric Sulfate %20 Dental Gel pulpotomy agent | Drug: Ferric Sulfate 20 % Dental Gel<br> <br> * Other names: Viscostat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total success rate | Number of molars with both clinically and radiographically successful | 6 months after pulpotomy treatment | 
| Total success rate | Number of molars with both clinically and radiographically successful | 12 months after pulpotomy treatment | 
| Total success rate | Number of molars with both clinically and radiographically successful | 24 months after pulpotomy treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpotomy, Primary molars