NCT01674933

Fluoride Varnish For Childsmile Nursery School Attenders

Comparison Of The Caries-Protective Effect Of Fluoride Varnish (Duraphat®) With Treatment As Usual In Nursery School Attendees Receiving Preventive Oral Health Support Through The Childsmile Oral Health Improvement Programme: An RCT

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,610 (estimated)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: 36 Months – 50 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Duraphat® Fluoride Varnish	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
BEHAVIORAL	treatment as usual	includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2012-08-29
• Last updated: 2017-10-26

Locations

4 sites across 1 country: United Kingdom