Dental caries in children Oral Health Dental caries
Conditions
Interventions
The application of fluoride varnish on the occlusal surfaces of the first permanent molars up to nine times over a three year period.
The control group had no intervention.
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Schools - all state maintained Local Authority primary schools in the study area. Participating schools must have formally agreed to take part int he study. 2. Children - Aged 7-8 years inclusive of children who attend Local Authority primary schools. Participants must have an informed consent form signed by a parent or legal guardian permitting participation of their child.
Exclusion criteria
Exclusion criteria: 1. Presence of fixed orthodontic appliances involving more than four permanent teeth 2. Participation in any other clinical study during the three months preceding the initial examination 3. Subjects with a history of asthma that required hospitalisation 4. Subjects with a histroy of severe allergic reactions that required hospitalisation 5. Subjects experiencing ulcerative gingivitis or stomatitis 6. Subjects with a history of allergy to any of the ingredients in the test products 7. Subject is uncooperative/ unable to be examined 8. Children attending special schools
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decayed, filled surfaces increment in first permanent molars on the intention-to-treat (ITT) population. The increment will be measured visually. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The decayed, filled surfaces increment in deciduous molars on the ITT population. The increment will be measured visually. 2. A sub group analysis for the frequency of applications of the varnish | — |
Countries
United Kingdom
Outcome results
None listed