Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies

Study Overview
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Brief Summary
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Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.

Detailed Description
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Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.

Official Title
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Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars

Conditions
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Primary Teeth, Pulpotomy

Intervention / Treatment
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* Device: MTA
* Drug: Ferric Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I,II Primary Molars diagnosed with normal or reversible pulpitis with vital carious pulp exposures Teeth that can have hemostasis can be achieved with pressure No clinical symptoms No radiographic signs of internal resorption or external root resorption Exclusion Criteria: Primary Molars diagnosed with irreversible pulpitis or necrotic pulp Teeth that can not achieve hemostasis Teeth with abscess or fistula Teeth that have radiographic signs of internal resorption or external resorption

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineral Trioxide Aggregate<br>Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth | Device: MTA<br>* Mineral Trioxide Aggregate grey paste<br>|
| Experimental: Ferric Sulfate<br>Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth | Drug: Ferric Sulfate<br>* Ferric Sulfate paste<br>* Other names: FS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical and Radiograph