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

Hargreaves 1973a.

Methods Quasi‐random allocation; double‐blind (A); placebo‐controlled; 5% drop out after 3 years (study duration = 3 years). Reasons for attrition NR; exclusions based on presence in all follow‐up examinations; any differential group losses not assessable.
Participants 284 children analysed at 3 years (present for all examinations).
 Age at start: 9 years.
 Surfaces affected at start: 6.3 DFS.
 Background exposure to fluoride: none reported.
 Year study began: 1968.
 Location: UK.
Interventions FT versus PL 
 (SMFP group = 2400 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Al oxide trihydrate.
Outcomes 3yNetDFS increment ‐ (E+U)(CA)cl+(ER)xr.
 Reported at 3 years follow up.
DFT.
 DMFS.
 DMFT.
 ECSI.
Notes Participants randomised (N = 298); numbers by group NR.
 Baseline characteristics (age, TAR, DFS, DMFS, DFT, DMFT, ECSI) 'balanced'.
 Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA; radiographic assessment (2 postBW) by two examiners; diagnostic threshold = ER. State of tooth eruption included = E/U. Diagnostic errors NR.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) High risk C ‐ Inadequate
HHS Vulnerability Disclosure