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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02492841 |
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Date of registration:
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27/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
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Scientific 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 |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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169 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02492841 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Chile
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Contacts
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Name:
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Claudia Brizuela |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de los Andes |
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Key inclusion & exclusion 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 .
Age minimum:
7 Years
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Caries
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Dental Pulp Exposure
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Intervention(s)
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Drug: Calcium hydroxide
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Drug: Biodentine
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Drug: Mineral trioxide aggregate
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Primary Outcome(s)
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Treatment Outcome
[Time Frame: 3 months, 6 moths and 12 months]
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Secondary Outcome(s)
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Adverse Effects
[Time Frame: 1 week, 3 and 6 months]
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Secondary ID(s)
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SA13I20175
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RPD-7-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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