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

Slack 1967a.

Methods Random allocation; double‐blind (A); placebo‐controlled; 21% drop‐out rate after 3 years (study duration = 3 years). Reasons for drop out described with numbers: left school, moved away, staining of teeth, on parents request; exclusions based on presence in all follow‐up examinations; no differential group losses.
Participants 757 children analysed at 3 years, all female
 (present for all examinations).
 Age range at start: 11‐12 years. Surfaces affected at start: 7 DFS.
 Background exposure to fluoride: none reported.
 Year study began: 1962.
 Location: UK.
Interventions FT versus PL 
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: dicalcium pyrophosphate.
Outcomes 3yDFS increment ‐ (E) (CA)cl.
 Reported at 3 years follow up.
DFT.
 DMFS.
 DMFT.
 postMD‐DFS.
Proportion of children with tooth staining.
Notes Participants randomised (N = 961).
 Baseline characteristics (age, dental age, DFS, DFT, DMFS, DMFT, TAR) 'balanced'.
 Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (2 postBW) by one examiner; diagnostic threshold = ER. Consistency of clinical diagnosis maintained by re‐examination of 10% sample and calibration checks made against reserve examiner.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure