The primary objective of this clinical trial was to assess the caries-preventive efficacy of 2 years of twice weekly supervised brushing with a self-applied gel containing 12,500 ppm fluoride on schooldays compared with weekly supervised use in children at high caries risk (with prior caries experience on first permanent molars). The secondary objective was to assess efficacy compared with similar children who continued with their usual oral hygiene care. This was a single-centre, single-blind, randomised, parallel-groups trial comprising two test groups and one untreated control group. 1,075 pupils aged 12–13 years at baseline received a baseline and final examination 2 years later. For all children completing the trial no significant difference was found between groups. For children compliant with study protocol no significant difference was found in the primary outcome (D1FS caries increment), but significant differences were found between the three groups overall in the secondary outcome, D3FT caries increment, with a significant pairwise difference between control and twice per week gel brushing (29%, p = 0.023 D3FT visual + fibre-optic transillumination). Analysis of the relationship between number of gel applications and caries showed that children who brushed with the gel at least 60 times over a 2-year period developed significantly fewer carious lesions into dentine than children who followed their usual oral hygiene routine. Some caution is needed as greatest benefit was shown by compliant children. Where schools are co-operative, it is recommended that the gel be used twice a week within a school-based programme over a 2-year period.

Curnow MMT, Pine CM, Burnside G, Nicholson JA, Chesters RK, Huntington E: A randomised controlled trial of the efficacy of supervised toothbrushing in high-caries-risk children. Caries Res 2002;36:294–300.
Department of Health (England): Delivering Better Oral Health: An evidence-based toolkit for prevention, ed 2. Department of Health/British Association for the Study of Community Dentistry, 2009.
Forgie AH, Pine CM, Pitts NB: The assessment of an intra-oral video camera as an aid to occlusal caries detection. Int Dent J 2003;53:3–6.
Goorhuis J, Purdell-Lewis DJ: 25% and 0.4% amine fluoride gel for weekly topical application. An in vivo study on human dental enamel. Caries Res 1986;20:458–464.
Konig KG: Role of fluoride toothpastes in a caries-preventive strategy. Caries Res 1993;27 (suppl 1):23–28.
Lagerweij MD, ten Cate JM: Remineralisation of enamel lesions with daily applications of a high-concentration fluoride gel and a fluoridated toothpaste: an in situ study. Caries Res 2002;36:270–274.
Madlena M, Nagy G, Gabris K, Marton S, Keszthelyi G, Banoczy J: Effect of amine fluoride toothpaste and gel in high risk groups of Hungarian adolescents: results of a longitudinal study. Caries Res 2002;36:142–146.
Marinho VC, Higgins JP, Logan S, Sheiham A: Fluoride gels for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2002;2:CD002280.
Marthaler TM: Caries status in Europe and predictions of future trends. Caries Res 1990;24:381–396.
Mitropoulos CM: The use of fibre-optic transillumination in the diagnosis of posterior approximal caries in clinical trials. Caries Res 1985;19:379–384.
Office of the Deputy Prime Minister: The English Indices of Deprivation 2004 (revised). London, ODPM Publications, 2004.
Pine CM, Curnow MM, Burnside G, Nicholson JA, Roberts AJ: Caries prevalence four years after the end of a randomised controlled trial. Caries Res 2007;41:431–436.
Pitts NB: Discovering dental public health: from Fisher to the future. Community Dent Health 1994;11:172–178.
Pitts NB, Boyles J, Nugent ZJ, Thomas N, Pine CM: The dental caries experience of 14-year-old children in England and Wales. Surveys co-ordinated by the British Association for the Study of Community Dentistry in 2002/2003. Community Dent Health 2004;21:45–57.
Pitts NB, Evans DJ, Nugent ZJ, Pine CM: The dental caries experience of 12-year-old children in England and Wales. Surveys coordinated by the British Association for the Study of Community Dentistry in 2000/ 2001. Community Dent Health 2002;19:46–53.
Ran F, Gedalia I, Fried M, Hadani P, Tved A: Effectiveness of fortnightly tooth brushing with amine fluorides in caries-prone subjects. J Oral Rehabil 1991;18:311–316.
Silness J, Löe H: Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand 1964;22:121–135.
Treide A, Treide B: Caries limiting effectiveness of newly developed fluoride-containing gels after 3 years clinical use in preschool years (in German). Stomatol DDR 1988;38:708–712.
Whittle KW, Whittle JG: Dental caries in 12-year-old children and the effectiveness of dental services in Salford, UK in 1960, 1988 and 1997. Br Dent J 1998;184:394–396.
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