Fluoride varnish for Childsmile nursery school attenders: an RCT

• Research type

  Research Study

• Full title

  Comparison of the caries-protective effect of fluoride varnish (Duraphat®) with treatment as usual in nursery school attenders receiving preventive oral health support through the Childsmile Programme: a Randomised Controlled Trial

• IRAS ID

  82255

• Contact name

  Lorna Macpherson

• Eudract number

  2012-002287-26

• Clinicaltrials.gov Identifier

  NCT01674933

• Research summary

  1. Four decades of clinical studies have demonstrated the effectiveness of Duraphat©. - the most commonly used brand ofluride varnish in Europe. However the percent caries reductions found in more recent studies have generally been lower than those reported earlier, probably because of the higher exposure to other preventive measures in more recent studies. It therefore cannot be assumed thafluride varnish will provide additional protection when applied alongside interventions already offered to children in nurseries. 2. The primary objective of the clinical trial is to compare the effectiveness of Duraphatfluride varnish in addition to usual treatment in the prevention of dental decay in children attending nursery school. 3. The study will take place among 3-5 years olds attending nursery schools. Study children would not be eligible for the Childsmile targetefluride varnishing programme, and so would not be denied potentially beneficial treatment that they would otherwise have received. 4. 805 nursery school children will be recruited into each arm of the two year trial. Sample size is based on two-sided significance level of 0.05 with 90% power to detect a 10% between-group difference (41% vs. 31%) in caries occurrence, assuming a 40% dropout rate. Thus if there is such a difference, this is likely to be due to the additional protection afforded by the varnish intervention. 5. The baseline dental inspection of consented and risk-assessed children will be carried out by a salaried dental practitioner, followed by randomisation to either Duraphatfluride varnish plus treatment as usual or treatment as usual only (control). 6fluride varnish treatment (or treatment as usual) will be repeated at 6, 12 and 18 months from the first application. Final data collection takes place at 24 months, in the first year of primary school, through a second blinded dental inspection.

• REC name

  West of Scotland REC 1

• REC reference

  12/WS/0136

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Favourable Opinion