Brudevold 1966.
Methods | Stratified random allocation; double‐blind ('A'); placebo‐controlled; 25% drop out (for all study groups combined) after 2 years (study duration = 2 years). Reasons for attrition NR; any differential group losses not assessable. | |
Participants | 1278 children analysed at 2 years (present for the entire trial period). Average age at start: 7‐16 years (average = 12). Surfaces affected at start: 15.7 DFS. Background exposure to fluoride: data not available for fluoridation status of site. Year study began: 1961. Location: USA. | |
Interventions | FT (3 groups)** versus 'PL'
(both SnF2 groups = 1000 ppm F, APF group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Ca pyrophosphate in one SnF2 toothpaste, IMP in the other SnF2 and in the APF toothpaste, control toothpaste abrasive NR. |
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Outcomes | 2yDFS increment ‐ cl+xr.
Reported at 2 years follow up. DMFS. DMFT. DFT. |
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Notes | Participants randomised (numbers for relevant groups NR). Baseline characteristics (dental age, DFS, DFT, DMFS, DMFT, gender) 'balanced'. Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA. Radiographic assessment (10 BW) by one examiner; diagnostic threshold NR. State of tooth eruption included NR. Diagnostic errors NR. **NaF‐secondary Ca phosphate toothpaste group not considered (abrasive system known to be incompatible with NaF). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |