title: Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay.
abstract: BACKGROUND
  Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting.
  
  
  METHODS
  The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6-7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars.
  
  
  CONCLUSIONS
  The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children.
  
  
  BACKGROUND
  ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273.
authors.affiliation: Applied Clinical Research and Public Health, Cardiff University School of Dentistry, Heath Park, Cardiff, CF14 4XY, UK. chestnuttig@cardiff.ac.uk
authors.forename: Ivor Gordon
authors.initials: IG
authors.lastname: Chestnutt
authors.forename: Barbara Lesley
authors.initials: BL
authors.lastname: Chadwick
authors.forename: Simon
authors.initials: S
authors.lastname: Hutchings
authors.forename: Rebecca
authors.initials: R
authors.lastname: Playle
authors.forename: Timothy
authors.initials: T
authors.lastname: Pickles
authors.forename: Catherine
authors.initials: C
authors.lastname: Lisles
authors.forename: Nigel
authors.initials: N
authors.lastname: Kirkby
authors.forename: Maria Zeta
authors.initials: MZ
authors.lastname: Morgan
authors.forename: Lindsay
authors.initials: L
authors.lastname: Hunter
authors.forename: Ceri
authors.initials: C
authors.lastname: Hodell
authors.forename: Beverely
authors.initials: B
authors.lastname: Withers
authors.forename: Simon
authors.initials: S
authors.lastname: Murphy
authors.forename: Sarah
authors.initials: S
authors.lastname: Morgan-Trimmer
authors.forename: Deborah
authors.initials: D
authors.lastname: Fitzsimmons
authors.forename: Ceri
authors.initials: C
authors.lastname: Phillips
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Nuttall
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
mesh_terms: D017438:Bisphenol A-Glycidyl Methacrylate / Q000627:therapeutic use; D002327:Cariostatic Agents / Q000191:economics / Q000627:therapeutic use*; D002648:Child; D002985:Clinical Protocols; D003149:Community Dentistry; D003362:Cost-Benefit Analysis; D004245:DMF Index; D003731:Dental Caries / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D005460:Fluorides, Topical / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007407:Interviews as Topic; D016014:Linear Models; D008297:Male; D008952:Mobile Health Units; D010043:Outcome and Process Assessment, Health Care; D010895:Pit and Fissure Sealants / Q000191:economics / Q000627:therapeutic use*; D011788:Quality of Life; D012571:School Dentistry; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D006113:United Kingdom; D035862:Vulnerable Populations; D014852:Wales
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical; D010895:Pit and Fissure Sealants; C023807:sodium fluoride topical preparation; D017438:Bisphenol A-Glycidyl Methacrylate; D012969:Sodium Fluoride