Horowitz 1966.
Methods | Quasi‐random allocation; double‐blind (A); placebo‐controlled; 40% drop‐out rate after 3 years (study duration = 3 years). Natural losses; no differential group losses. | |
Participants | 638 children analysed at 3 years (available at final examination). Age range at start: 6‐10 years. Surfaces affected at start: 2.08 DMFS. Background exposure to fluoride: none reported. Year study began: 1961. Location: USA. | |
Interventions | FT versus PL **
(SnF2 group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Ca pyrophosphate. |
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Outcomes | 3yNetDMFS increment ‐ (E+U) (CA)cl.
Reported at 1, 2, and 3 years follow ups. DMFT. |
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Notes | Participants randomised (N = 1059). Baseline characteristics (DMFS, DMFT, TAR) 'balanced'. Clinical (VT) caries assessment by three examiners; diagnostic threshold = CA; state of tooth eruption included = E/U. Reversals were small in both groups (about 3% of DMFS increments) and equally common (NS different). ** Only relevant comparison (others were not randomised/quasi‐randomized) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | High risk | C ‐ Inadequate |