Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements

Study Overview
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Brief Summary
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The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).

Detailed Description
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This prospective randomized clinical trial study has been approved by the Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group). The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P <0.05.

Official Title
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Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.

Conditions
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Primary Molar Pulpotomy

Intervention / Treatment
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* Other: MTA Pro Root
* Other: MTA HP Repair
* Other: Biodentine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form. Children under 18 years of age with informed parental consent, correctly understood. Patient understands and is willing to comply with all study procedures and restrictions. Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation. Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal. Exclusion Criteria: Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality). Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied. Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulp Dressing MTA Angelus<br>pulp therapy | Other: MTA HP Repair<br>* pulp therapy<br>|
| Experimental: Pulp Dressing MTA Pro Root<br>pulp therapy | Other: MTA Pro Root<br>* pulp therapy<br>|
| Experimental: Pulp Dressing Biodentine<br>pulp therapy | Other: Biodentine<br>* pulp therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual examination | Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination. | 12 months | 
| Radiographic Success | RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radicular Radiolucency | RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis. | 12 months | 
| Internal Resorption | RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption. | 12 months | 
| External Resorption | RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption. | 12 months | 
| Furcation Radiolucency | RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis. | 12 months | 
| Symptoms of pain | Clinical examination,The patient will be recalled for control . Data will be recorded in terms of presence of symptoms, clinical and radiographic signs of success / failure, vertical and lateral percussion, periodontal probing and periapical and bitewing be implemented following the same methodology as in the initial evaluation.Clinical failure was determined by the subjective symptoms as explained by the participants. | 12 months | 
| Swelling | Clinical examination . Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including swelling. | 12 months | 
| Fistulation | Clinical and RX examination,The patient will be recalled for control .Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including abscess. | 12 months | 
| Pathological Mobility | Clinical examination,The patient will be recalled for control.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including mobility. | 12 months |