Ashley 1977.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 12% drop out (for all study groups combined) after 2 years (study duration = 2 years). Natural losses; any differential group losses not assessable. | |
Participants | 489 children analysed at 2 years (available at final examination). Average age at start: 12 years. Surfaces affected at start: 9.1 DFS. Background exposure to fluoride: none. Year study began: 1973. Location: UK. | |
Interventions | FT versus PL
(SMFP group = 1000 ppm F). School use/supervised, daily, 1g applied for 1 min, post‐brushing water rinse done (non‐fluoride toothpaste provided to all for home use). Abrasive system: IMP (main abrasive). |
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Outcomes | 2yNetDFS increment ‐ (E+U)(NCA)cl+(ER)xr.
Reported at 2 years follow up. PF‐DFS. MD‐BL‐DFS. MD‐DFS. DFS (U). |
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Notes | Participants randomised (numbers for relevant groups NR). Baseline characteristics (age, DFS, DMFS, DMFT) 'balanced'. Clinical (V) caries assessment by one examiner (FOTI used); diagnostic threshold = NCA. Radiographic assessment (postBW) by one examiner; diagnostic threshold = ER. State of tooth eruption included = E/U. Intra‐examiner reproducibility checks for incremental caries data (icc for clinical 0.95, for radiographic 0.8); reversal rate between 12% and 7% of observed DFS increment in study groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |