title: Fissure Seal or Fluoride Varnish? A Randomized Trial of Relative Effectiveness.
abstract: Fissure sealant (FS) and fluoride varnish (FV) are effective in preventing dental caries when compared with a no-treatment control. However, the relative clinical effectiveness of these interventions is uncertain. The objective of the study was to compare the clinical effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- to 7-y-olds. The study design was a randomized clinical trial, with 2 parallel arms. The setting was a targeted-population program that used mobile dental clinics in schools located within areas of high social and economic deprivation in South Wales. A total of 1,016 children were randomized 1:1 to receive either FS or FV. Resin-based FS was applied to caries-free FPMs and maintained at 6-mo intervals. FV was applied at baseline and at 6-mo intervals for 3 y. The main outcome measures were the proportion of children developing caries into dentine (D4-6MFT) on any 1 of up to 4 treated FPMs after 36 mo. At 36 mo, 835 (82%) children remained: 417 in the FS arm and 418 in the FV arm. A smaller proportion of children who received FV ( n = 73, 17.5%) versus FS ( n = 82, 19.6%) developed caries into dentine on at least 1 FPM (odds ratio [OR] = 0.84; 95% CI, 0.59 to 1.21; P = 0.35), a nonstatistically significant difference between FS and FV treatments. The results were similar when the number of newly decayed teeth (OR = 0.86; 95% CI, 0.60 to 1.22) and tooth surfaces (OR = 0.85; 95% CI, 0.59 to 1.21) were examined. In a community oral health program, semiannual application of FV resulted in caries prevention that was not significantly different from that obtained by applying and maintaining FS after 36 mo (EudraCT: 2010-023476-23; ISRCTN: ISRCTN17029222).
authors.affiliation: 1 Applied Clinical Research and Public Health, School of Dentistry, Cardiff University, Cardiff, UK.
authors.forename: I G
authors.initials: IG
authors.lastname: Chestnutt
authors.affiliation: 1 Applied Clinical Research and Public Health, School of Dentistry, Cardiff University, Cardiff, UK.|2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: R
authors.initials: R
authors.lastname: Playle
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: S
authors.initials: S
authors.lastname: Hutchings
authors.affiliation: 3 DECIPHer, School of Social Sciences, Cardiff University, Cardiff, UK.
authors.forename: S
authors.initials: S
authors.lastname: Morgan-Trimmer
authors.affiliation: 4 Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, UK.
authors.forename: D
authors.initials: D
authors.lastname: Fitzsimmons
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: N
authors.initials: N
authors.lastname: Aawar
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: L
authors.initials: L
authors.lastname: Angel
authors.affiliation: 5 Community Dental Service, Cardiff and Vale University Health Board, Whitchurch Hospital, Cardiff, UK.
authors.forename: S
authors.initials: S
authors.lastname: Derrick
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: C
authors.initials: C
authors.lastname: Drew
authors.affiliation: 5 Community Dental Service, Cardiff and Vale University Health Board, Whitchurch Hospital, Cardiff, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hoddell
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: K
authors.initials: K
authors.lastname: Hood
authors.affiliation: 4 Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, UK.
authors.forename: I
authors.initials: I
authors.lastname: Humphreys
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: N
authors.initials: N
authors.lastname: Kirby
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: T M M
authors.initials: TMM
authors.lastname: Lau
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: C
authors.initials: C
authors.lastname: Lisles
authors.affiliation: 1 Applied Clinical Research and Public Health, School of Dentistry, Cardiff University, Cardiff, UK.
authors.forename: M Z
authors.initials: MZ
authors.lastname: Morgan
authors.affiliation: 3 DECIPHer, School of Social Sciences, Cardiff University, Cardiff, UK.
authors.forename: S
authors.initials: S
authors.lastname: Murphy
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: J
authors.initials: J
authors.lastname: Nuttall
authors.affiliation: 4 Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, UK.
authors.forename: K
authors.initials: K
authors.lastname: Onishchenko
authors.affiliation: 4 Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, UK.
authors.forename: C
authors.initials: C
authors.lastname: Phillips
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: T
authors.initials: T
authors.lastname: Pickles
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: C
authors.initials: C
authors.lastname: Scoble
authors.affiliation: 2 South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.
authors.forename: J
authors.initials: J
authors.lastname: Townson
authors.affiliation: 5 Community Dental Service, Cardiff and Vale University Health Board, Whitchurch Hospital, Cardiff, UK.
authors.forename: B
authors.initials: B
authors.lastname: Withers
authors.affiliation: 1 Applied Clinical Research and Public Health, School of Dentistry, Cardiff University, Cardiff, UK.
authors.forename: B L
authors.initials: BL
authors.lastname: Chadwick
mesh_terms: D002327:Cariostatic Agents / Q000627:therapeutic use*; D002648:Child; D019140:Dental Care for Children / Q000458:organization & administration*; D003731:Dental Caries / Q000517:prevention & control*; D005260:Female; D005460:Fluorides, Topical / Q000627:therapeutic use*; D006293:Health Promotion; D006801:Humans; D008297:Male; D010895:Pit and Fissure Sealants / Q000627:therapeutic use*; D016896:Treatment Outcome; D014852:Wales
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical; D010895:Pit and Fissure Sealants
keywords: clinical effectiveness; clinical trial; dental caries; dental public health; molar; prevention