Fluoride varnish for Childsmile nursery school attenders
- Conditions
- Childhood dental cariesMedDRA version: 14.1Level: PTClassification code 10012318Term: Dental cariesSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2012-002287-26-GB
- Lead Sponsor
- Greater Glasgow and Clyde NHS Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1284
1. Attendance at a Local Authority nursery school or class as a ante pre-school attendee (entry after third birthday).
2. Participating nurseries will serve significant numbers of children whose home postcode is within the most deprived quintile of postcodes as measured by the Scottish Index of Multiple Deprivation. Every eligible child in participating nurseries will be invited to join the study, irrespective of the SIMD ranking of their own postcode.
3. Children with or without pre-existing cavities are included, as the cavity can be treated through the usual primary care dental service (ie as part of ‘treatment as usual’).
Are the trial subjects under 18? yes
Number of subjects for this age range: 1610
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•Children with contraindications for Duraphat varnish i.e.
hypersensitivity to colophony and/or any other constituents,
ulcerative gingivitis,
stomatitis,
bronchial asthma,
history of allergic episodes requiring hospital admission (eg for asthma).
2. Receipt of fluoride supplements, due to a small risk of fluorosis.
3. Abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue lesions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method