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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01038817 |
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Date of registration:
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22/12/2009 |
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Primary sponsor: |
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Public title:
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Impact of Fluoride Vanish Application in Dental Prevention for Elderly
VERNIS |
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Scientific title:
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Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01038817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe Charru |
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Address:
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Telephone:
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01 47 60 66 80 |
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Email:
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philippe.charru@lmr.aphp.fr |
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Affiliation:
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Name:
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Philippe Charru |
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Address:
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Telephone:
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01 47 60 66 80 |
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Email:
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philippe.charru@lmr.aphp.fr |
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Affiliation:
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Name:
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Marysette Folliguet |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Public Hôpitaux de Paris |
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Name:
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Philippe Charru |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Public Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient hospitalised in nursing home or long-stay hospital department
- patient older than 18 years old
- obtention of informed consent
- 3 or more healthy or treated teeth on each side (left and right) of the mandibles
Exclusion Criteria:
- patient in palliative care or end-of-life care
- patient without social security affiliation
- patient participating in another research dealing with dental care
- contra-indication to fluoride varnish
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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Tooth Decay
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Intervention(s)
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Drug: Duraphat
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Primary Outcome(s)
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incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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