Jackson 1967.
Methods | Quasi‐random allocation; double‐blind (A); placebo‐controlled; 12% drop‐out rate after 3 years (study duration = 3 years). Natural losses; no differential group losses. | |
Participants | 871 children analysed at 3 years (available at final examination). Age range at start: 11‐12 years. Surfaces affected at start: 8.7 DMFS. Background exposure to fluoride: none reported. Year study began: 1962. Location: UK. | |
Interventions | FT versus PL
(SnF2 group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: dicalcium pyrophosphate. |
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Outcomes | 3yDMFS increment ‐ (E+U)(CA)cl.
Reported at 3 years follow up. DMFT. Proportion of caries‐free teeth/surfaces (by tooth type/ surface type) which developed caries. Proportion of children who complained of tooth staining. |
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Notes | Participants randomised (N = 986). Baseline characteristics (age, DMFS, DMFT, TAR, level of treatment, staining) 'balanced'. Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included = E/U. 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) | High risk | C ‐ Inadequate |