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. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

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).
Outcomes 2yNetDFS increment ‐ (E+U)(NCA)cl+(ER)xr.
 Reported at 2 years follow up.
PF‐DFS.
 MD‐BL‐DFS.
 MD‐DFS.
 DFS (U).
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
HHS Vulnerability Disclosure