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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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11 October 2021 |
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Main ID: |
NCT03470129 |
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Date of registration:
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06/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Performance of Two Fissure Sealants
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Scientific title:
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Klinische Bewährung Zweier Fissurenversiegler |
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Date of first enrolment:
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July 1, 2018 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03470129 |
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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: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Switzerland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
participants
- ASA Status 1
- all dentinal lesions are restored
- consent of parents and patient
- instruction and demonstration of oral hygiene
teeth:
- first and second molars of the permanent dentition
- healthy teeth without caries
- molars with primary lesions
Exclusion Criteria:
participants
- no consent
- allergies to methacrylates or other ingredients of dental products
teeth:
- molars with occlusal cavities (UniViSS score occlusal > M)
- Molars with untreated dentinal lesions
- premolars, incisors, deciduous teeth
- teeth with huge occlusal restorations
- hypomineralized teeth or other defects
Age minimum:
5 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Caries Pit and Fissure Limited to Enamel
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Intervention(s)
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Device: fissure sealing
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Primary Outcome(s)
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retention of the sealant
[Time Frame: 7-28 days]
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retention of sealant
[Time Frame: 24 months]
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retention of sealant
[Time Frame: 12 months]
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retention of sealant
[Time Frame: 6 months]
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Secondary Outcome(s)
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caries
[Time Frame: 6 months]
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caries
[Time Frame: 7-28 days]
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caries
[Time Frame: 12 months]
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caries
[Time Frame: 24 months]
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Secondary ID(s)
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Helioseal F Plus
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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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