Skip to main content
. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

Koch 1967a.

Methods Stratified random allocation***; double‐blind (A); placebo‐controlled; 18% drop out after 3 years (study duration = 3 years + 2 years post‐intervention period). Natural losses; no differential group losses.
Participants 120 children analysed at 3 years (present for entire trial period).
 Age range at start: 11‐12 years (average = 11).
 Surfaces affected at start: 19.7 DFS.
 Background exposure to fluoride: none reported.
 Year study began: 1962.
 Location: Sweden.
Interventions FT versus PL 
 (NaF group = 1000 ppm F).
School use/supervised, daily, 1g applied for 2 min (non‐fluoride toothpaste provided to all for home use). 
 Abrasive system: methacrylate polymer (acrylic).
Outcomes 3yDFS increment ‐ cl(CA)(E).
 Reported at 1 and 3 years follow ups (and 2 years post‐treatment).
DFT.
 O‐DFS.
 MD‐DFS.
 BL‐DFS.
 Annual CAR.
 Secondary caries.
Notes Participants randomised (N = 146).
 Baseline characteristics (DFS, DFT, 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.
 Intra‐examiner reproducibility checks for DFS in 10% sample (icc over 0.98); reversals very small in both groups and equally common.
 *** 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