Slack 1967.
Methods | Random allocation; double‐blind (A); placebo‐controlled; 21% drop‐out rate after 3 years (study duration = 3 years). Reasons for drop out described with numbers: left school, moved away, staining of teeth, on parents request; exclusions based on presence in all follow‐up examinations; no differential group losses. | |
Participants | 696 children analysed at 3 years, all female (present for all examinations). Average age at start: 11 years. Surfaces affected at start: 8.9 DFS. Background exposure to fluoride: none reported. Year study began: 1963. Location: UK. | |
Interventions | FT versus PL
(SnF2 group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: IMP (dicalcium phosphate (dihydrate) in placebo toothpaste also). |
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Outcomes | 3yNetDFS increment ‐ (E)(CA)cl.
Reported at 3 years follow up. DFT. DMFS. DMFT. postMD‐DFS. Proportion of children with tooth staining. |
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Notes | Participants randomised (N = 886). Baseline characteristics (age, dental age, DFS, DFT, DMFS, DMFT, TAR) 'balanced'. Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (2 postBW) by one examiner; diagnostic threshold = ER. Consistency of clinical diagnosis maintained by re‐examination of 10% sample and calibration checks made against reserve examiner. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |