Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Study Overview
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Brief Summary
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Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation. Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

Detailed Description
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Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

Official Title
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Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years

Conditions
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Caries, Dental Pulp Exposure

Intervention / Treatment
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* Drug: Mineral trioxide aggregate
* Drug: Calcium hydroxide
* Drug: Biodentine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients Patients with at least one full or partial tooth root development Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration Teeth that have pulp exposure not exceeding 1 mm in size. Exclusion Criteria: Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineral trioxide aggregate (MTA)<br>Mineral trioxide aggregate Root canal repair material | Drug: Mineral trioxide aggregate<br>* Mineral trioxide aggregate<br>* Other names: MTA Pro Root;|
| Active Comparator: Calcium hydroxide<br>-material for pulp capping | Drug: Calcium hydroxide<br>* Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.<br>* Other names: Calcium hydroxide Hertz;|
| Experimental: Biodentine<br>Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping | Drug: Biodentine<br>* Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.<br>* Other names: Active biosilicate. Septodont.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Outcome | vitality test with electric device cold and hot test radiographic evaluation | 3 months, 6 moths and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects | Name any adverse effects. | 1 week, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dentin substitute, vital pulp therapy, Biodentine, caries