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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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19 February 2015 |
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Main ID: |
NCT02234609 |
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Date of registration:
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25/08/2014 |
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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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Effectiveness of Modified Class IV Atraumatic Restorative Treatment
modARTIV |
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Scientific title:
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Effectiveness of Modified Class IV Atraumatic Restorative Treatment - Results After 12 Months |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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69 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02234609 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Stefan Zimmer, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Witten/Herdecke University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- informed consent
Exclusion Criteria:
- no class IV cavity
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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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Device: modified ART class IV
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Primary Outcome(s)
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Number (and percentage) of class IV modified ART restorations with failures after 1 year of performance (failures are defined as loss of restoration and/or fractures): annual failure rate
[Time Frame: 1 year]
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Secondary Outcome(s)
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9 scale clinical evaluation scores of class IV modified ART restorations after 1 year of performance (scores are defined by Frencken et al. 1996): ART evaluation criteria
[Time Frame: 1 year]
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Secondary ID(s)
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76/2011
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mARTIV
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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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