A cluster randomised control trial to measure the benefit of fluoride varnish in preventing dental decay when applied to the permanent teeth of children for three years in the school setting - Fluoride varnish to prevent dental decay in young childre
Phase 1
- Conditions
- Dental caries in first permanent molars
- Registration Number
- EUCTR2005-003845-15-GB
- Lead Sponsor
- niversity of Manchester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 6800
Inclusion Criteria
All Children in state maintained schools aged 7-8 years(at baseline) in Burnley, Pendle and Rossendale, Blackburn with Darwen and Hyndburn and Ribble Valley PCTs whose parents consent to their participation will be included.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Excluded children will be those whose parents do not consent to their participation, or have serious allergies including asthma.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Main Objective: To determine if fluoride varnish (Duraphat) applied in the school setting 3 times a year for 3 years to the biting surfaces of the permanent back teeth of children aged 6-8 years at the start of the study, leads to reduced levels of dental decay in the permanent back teeth when compared with a control group receiving no Duraphat.;<br> Primary end point(s): It is the last dental examination of the last subject included in the study.<br>
- Secondary Outcome Measures
Name Time Method