Abstract
Design This was a double-blind randomised controlled trial (RCT) conducted over a period of 4 years.
Intervention The trial used a semi-annual dental check-up with preventive treatment which consisted of oral hygiene instruction followed by supervised brushing with fluoride toothpaste and either application of a neutral 1% sodium fluoride gel (4500 ppm) or a placebo gel. After the application of the gel participants were advised to refrain from rinsing, eating or drinking for 30 min.
Outcome measure Caries experience was recorded, measured by D3MFS and by prevented fraction (PF).
Results The mean caries reduction of professionally applied fluoride gel after 4 years, in subjects with baseline caries experience of D3MFS=0 as well as d3mfs=0 was 0.08 D3MFS (standard error (SE), 0.06) and 0.36 d3mfs (SE, 0.22). The PF for D3MFS and d3mfs was 26% (SE, 16%) and 20% (SE, 11%), respectively. This equates to a number-needed-to-treat of 50 in order to save a subject from 1 D3MFS after 4 years.
Conclusions In 4.5- to 6.5-year-old children who had low risk of caries, fluoride gel treatment showed a statistically significant caries-inhibiting effect on D3MFS, which was considered not clinically relevant, and showed no significant effect on d3mfs.
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References
Clarke M, Alderson P, Chalmers I . Discussion sections in reports of controlled trials published in general medical journals. J Am Med Assoc 2002; 287:2799–2801.
van Rijkom HM, Truin GJ, van't Hof MA . A meta-analysis of clinical studies on the caries-inhibiting effect of fluoride gel treatment. Caries Res 1998; 32:83–92.
Marinho VCC, Higgins JPT, Logan S, Sheiham A . Fluoride gels for preventing dental caries in children and adolescents. The Cochrane Database of Systematic Reviews 2002; Issue 1.
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Address for correspondence: Gert-Jan Truin, Department of Preventive and Community Dentistry and Pedodontology, University of Nijmegen Medical Centre, Nijmegen, The Netherlands.
van Rijkom HM, Truin GJ, van't Hof MA. Caries-inhibiting effect of professional fluoride gel application in low-caries children initially aged 4.5–6.5 years. Caries Res 2004; 38:115–123
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Marinho, V. Fluoride gel inhibits caries in children who have low caries-risk but this may not be clinically relevant. Evid Based Dent 5, 95 (2004). https://doi.org/10.1038/sj.ebd.6400293
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DOI: https://doi.org/10.1038/sj.ebd.6400293
