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

Blinkhorn 1983.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 10% drop out after 3 years (study duration = 3 years). Reasons for attrition described with respective total numbers: 57 left school, 12 withdrawn by parents, 6 absent at final examination; no differential group losses.
Participants 368 children analysed at 3 years (available at final examination).
 Age range at start: 11‐12 years.
 Surfaces affected at start: 8.2 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: 1972.
 Location: UK.
Interventions FT versus PL 
 (SMFP group = 1000 ppm F).
School use/supervised, daily, for 1 min, post‐brushing water rinse done (appropriate toothpastes also provided for home use).
 Abrasive system: IMP (main abrasive).
Outcomes 3yNetDFS increment ‐ (E+U)(CA)cl+(DR)xr.
 Reported at 3 years follow up.
PF‐DFS.
 MD‐BL‐DFS.
 MD‐DFS.
 postMD‐DFS.
 DFS (U).
 DMFT.
 anterior DMFT.
 posterior DMFT.
 DMFT (U).
Notes Participants randomised (N = 410).
 Baseline characteristics (DMFS, DMFT, SAR) 'balanced' (DFS baseline data NR).
 Clinical (V) caries assessment by one examiner, diagnostic threshold = CA. Radiographic assessment (1 postBW) by one examiner; diagnostic threshold = DR. State of tooth eruption included = E/U. Intra‐examiner reproducibility checks for incremental clinical and radiographic caries data in 10% sample (icc score 0.9).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure