Zacherl 1970.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 43% drop out after 2.5 years (study duration = 2.5 years). Reasons for high drop out NR; no differential group losses. | |
Participants | 512 children analysed at 2.5 years (available at final examination). Age range at start: 6‐9 years. Surfaces affected at start: 4.6 DMFS. Background exposure to fluoride: none reported. 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 | 2.5yDMFS increment ‐ cl+xr.
Reported at 10 m, 1.5 and 2.5 years follow ups. DMFT. |
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Notes | Participants randomised (N = 902). Baseline characteristics (dental age, gender, DMFS, DMFT, oral hygiene) 'balanced'. Clinical (VT) caries assessment by one examiner, diagnostic threshold = NR. Radiographic assessment (5‐10 BW) by one examiner; 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) | High risk | C ‐ Inadequate |