title: Comparison of the caries-protective effect of fluoride varnish with treatment as usual in nursery school attendees receiving preventive oral health support through the Childsmile oral health improvement programme - the Protecting Teeth@3 Study: a randomised controlled trial.
abstract: BACKGROUND
  The Scottish Government set out its policy on addressing the poor oral health of Scottish children in 2005. This led to the establishment of Childsmile, a national programme designed to improve the oral health of children in Scotland. One element of the programme promotes daily tooth brushing in all nurseries in Scotland (Childsmile Core). A second targeted component (Childsmile Nursery) offers twice-yearly application of fluoride varnish to children attending nurseries in deprived areas. Studies suggest that fluoride varnish application can reduce caries in both adult and child populations. This trial aims to explore the effectiveness and cost-effectiveness of additional preventive value fluoride varnish application compared to Childsmile Core.
  
  
  METHODS
  The Protecting Teeth@3 Study is an ongoing 2 year parallel group randomised treatment as usual controlled trial. Three-year-old children attending the ante pre-school year are randomised (1:1) to the intervention arm (fluoride varnish & treatment as usual) or the control arm (treatment as usual). Children in the intervention arm will have Duraphat® fluoride varnish painted on the primary tooth surfaces and will continue to receive treatment as usual: the core Childsmile Nursery intervention. Children in the treatment as usual arm will receive the same series of contacts, without the application of varnish and will also continue with the Childsmile Core intervention. Interventions are undertaken by Childsmile trained extended duty dental nurses at six-monthly intervals. Participants receive a baseline dental inspection in nursery and an endpoint inspection in Primary 1 at the age of 5 years old. We will use primary and secondary outcome measures to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual with treatment as usual only in preventing any further dental decay. We will also undertake a full economic evaluation of the trial.
  
  
  BACKGROUND
  This study is registered at ClinicalTrials.gov. Number: NCT01674933 (24 August 2012).
authors.affiliation: Community Oral Health, University of Glasgow Dental School, 378 Sauchiehall Street, Glasgow, G2 3JZ, Scotland, UK. william.wright@glasgow.ac.uk.
authors.forename: William
authors.initials: W
authors.lastname: Wright
authors.affiliation: Community Oral Health, University of Glasgow Dental School, 378 Sauchiehall Street, Glasgow, G2 3JZ, Scotland, UK. s.turner@dundee.ac.uk.
authors.forename: Stephen
authors.initials: S
authors.lastname: Turner
authors.affiliation: Community Oral Health, University of Glasgow Dental School, 378 Sauchiehall Street, Glasgow, G2 3JZ, Scotland, UK. yulia.Anopa@glagow.ac.uk.
authors.forename: Yulia
authors.initials: Y
authors.lastname: Anopa
authors.affiliation: Health Economic and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, Scotland, UK. emma.mcintosh@glasgow.ac.uk.
authors.forename: Emma
authors.initials: E
authors.lastname: McIntosh
authors.affiliation: Health Economic and Health Technology Assessment, Institute of Health & Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, Scotland, UK. olivia.wu@glasgow.ac.uk.
authors.forename: Olivia
authors.initials: O
authors.lastname: Wu
authors.affiliation: Community Oral Health, University of Glasgow Dental School, 378 Sauchiehall Street, Glasgow, G2 3JZ, Scotland, UK. david.conway@glasgow.ac.uk.
authors.forename: David I
authors.initials: DI
authors.lastname: Conway
authors.affiliation: Community Oral Health, University of Glasgow Dental School, 378 Sauchiehall Street, Glasgow, G2 3JZ, Scotland, UK. lorna.macpherson@glasgow.ac.uk.
authors.forename: Lorna M D
authors.initials: LM
authors.lastname: Macpherson
authors.affiliation: Community Oral Health, University of Glasgow Dental School, 378 Sauchiehall Street, Glasgow, G2 3JZ, Scotland, UK. Alex.McMahon@glasgow.ac.uk.
authors.forename: Alex D
authors.initials: AD
authors.lastname: McMahon
mesh_terms: D002327:Cariostatic Agents / Q000008:administration & dosage*; D002675:Child, Preschool; D003731:Dental Caries / Q000517:prevention & control*; D005459:Fluorides / Q000008:administration & dosage*; D005460:Fluorides, Topical; D006801:Humans; D009909:Oral Health; D012107:Research Design; D012578:Schools, Nursery; D012606:Scotland
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical; D005459:Fluorides