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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02849925 |
Date of registration:
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21/07/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Sealing Microcavitated Carious Lesions
SealCaries |
Scientific title:
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Randomized Controlled Clinical Trial on the Treatment of Caries Lesions Using Resin or Glass Ionomer Sealants in Permanent Teeth |
Date of first enrolment:
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March 2015 |
Target sample size:
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37 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02849925 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Chile
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- To have at least one ICDAS 3 lesion in first permanent molars
- To be systemically healthy
Exclusion Criteria:
- Not fully erupted first molars
- Structural defects in first molars, i.e., hypoplasia, fluorosis, MIH.
- Periodontal disease
- Orthodontic appliances
- Medication use
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dental Caries
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Intervention(s)
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Drug: Sealants to arrest microcavitated caries.
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Primary Outcome(s)
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Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions.
[Time Frame: 24 months]
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Secondary Outcome(s)
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Percentage of sealants that were intact from the first intervention over time.
[Time Frame: 24 months]
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Percentage of sealants that were fractured or lost during the follow-up.
[Time Frame: 24 months]
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Secondary ID(s)
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RCTICDAS3/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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