Background: Dental caries remains a significant public health problem, prevalence being linked to social and\r\neconomic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing\r\npermanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be\r\neffective over no intervention in preventing caries. However, the comparative cost and effectiveness of these\r\ntreatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical\r\neffectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims\r\ninclude: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school\r\nsetting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/\r\ntreatment acceptability measures; and examining the implementation of treatment in a community setting.\r\nMethods/design: The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6ââ?¬â??7\r\nyear old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived\r\nareas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited\r\n(460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International\r\nCaries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by\r\ntrained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at\r\nbaseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become\r\ndetached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process\r\nevaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and\r\ninterviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the\r\nproportion of children developing new caries on any one of up to four treated first permanent molars.\r\n(Continued on next page) Discussion: The objectives of this study have been identified by the National Institute for Health Research as one\r\nof importance to the National Health Service in the UK. The results of this trial will provide guidance on which of\r\nthese technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in\r\nthe most at risk children.
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