The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any further dental decay among 3-4 year old children in nursery schools. It is important to ascertain the additional preventive value that fluoride varnish may provide when applied in conjunction with other preventive measures which form part of a national dental health improvement programme targeting children at risk from dental decay. 1600 children will be recruited into the study for 2 years.
The objective of this study is to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual (TAU) with TAU only in preventing any further dental decay. Thus the study is a clinical trial of treatment as usual (TAU) versus TAU plus fluoride varnish in the nursery school setting. TAU is the core Childsmile Nursery intervention (supervised daily toothbrushing with fluoride toothpaste, free dental packs of fluoride toothpaste, toothbrushes and advice). Children will be screened by asking parents whether or not the child has previously been hospitalised with asthma or diagnosed with any allergies. Provided that a child has no contraindications to fluoride varnish then the child can proceed to study inclusion. On the day of the planned application, the dental nurse will carry out a risk assessment to reduce the possibility of children with oral/facial infections being included. After excluding non-eligible children, a baseline dental examination will take place, followed by randomisation into treatment as usual or treatment as usual plus fluoride varnish. This second group will receive up to four fluoride varnish applications at 6 month intervals. After two years, all study children will be offered a final dental examination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,610
0.25 ml per application will be painted on tooth surfaces by a Childsmile trained Extended Duties Dental Nurse, currently registered with the UK General Dental Council
includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
NHS Lothian
Edinburgh, Scotland, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
NHS Fife
Kirkcaldy, Scotland, United Kingdom
NHS Tayside
Perth, Scotland, United Kingdom
d3mft ( a standard measure of dental health (number of teeth where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth)
d3mft is a standard measure of dental health (number of teeth where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth).
Time frame: 24 months
d3mfs
a standard measure of dental health, comprising the number of tooth surfaces where decay which has penetrated the tooth enamel, plus the number of missing or filled teeth
Time frame: 24 months
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