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

Koch 1967b.

Methods Stratified random allocation***; double‐blind (A); placebo‐controlled; 19% drop out after 2 years (study duration = 2 years). Natural losses; any differential group losses not assessable.
Participants 70 children analysed at 2 years (present for entire trial period).
 Age range at start: 13‐14 years. 
 Surfaces affected at start: 30.1 DFS.
 Background exposure to fluoride: none reported.
 Year study began: 1963.
 Location: Sweden.
Interventions FT versus PL 
 (NaF group = 1000 ppm F).
Home use/unsupervised, twice a day instructed frequency but daily frequency assumed, for 2 min. 
 Abrasive system: methacrylate polymer (acrylic).
Outcomes 2yDFS increment ‐ cl(CA)(E).
 Reported at 2 years follow up.
DFT.
 O‐DFS.
 MD‐DFS.
 BL‐DFS.
 Annual CAR.
 Secondary caries.
Notes Participants randomised (N = 86); numbers by group NR.
 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