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

Koch 1967c.

Methods Stratified random allocation***; double‐blind (A); placebo‐controlled; 19% drop out after 3 years (study duration = 3 years). Natural losses; no differential group losses.
Participants 255 children analysed at 3 years (present for entire trial period).
 Age range at start: 7‐10 years. Surfaces affected at start: 7.9 DFS. 
 Background exposure to fluoride: none reported.
 Year study began: 1962.
 Location: Sweden.
Interventions FT versus PL 
 (NaF group = 1000 ppm F).
School clinic/supervised, 3 times a year, 1g applied for 2 min (no provision of any toothpaste reported for home use). 
 Abrasive system: methacrylate polymer (acrylic).
Outcomes 3yDFS increment ‐ cl(CA)(E).
 Reported at 1 and 3 years follow ups.
DFT.
 Annual CAR.
 Secondary caries.
Notes Participants randomised (N = 316).
 Baseline characteristics (FS, FT, SAR, TAR) 'balanced'.
 Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; radiographic assessment (2 postBW) used as an aid but not reported; state of tooth eruption included = E. Diagnostic errors NR.
 *** Allocation concealment considered adequate by consensus.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate
HHS Vulnerability Disclosure