Gish 1966.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 34% drop out after 3 years (study duration = 5 years). Reasons for attrition NR; any differential group losses not assessable. | |
Participants | 328 children analysed at 3 years (available at final examination). Age range at start: 6‐14 years (average = 9). Surfaces affected at start: 3.9 DMFS. Background exposure to fluoride: water. Year study began: in/before 1963. 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 | 3yDMFS increment ‐ cl+xr.
Reported at 1, 2, 3, 4 and 5 years follow ups. DMFT. |
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Notes | Participants randomised (N = 500); numbers by group NR. Baseline characteristics (age, DMFS) 'balanced'. Clinical (VT) caries assessment by two examiners, diagnostic threshold = NR. Radiographic assessment (5‐7 BW); diagnostic threshold = NR. State of tooth eruption included = NR. Diagnostic errors NR. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |