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

Gish 1966.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 34% drop out after 3 years (study duration = 5 years). Reasons for attrition NR; any differential group losses not assessable.
Participants 328 children analysed at 3 years (available at final examination).
 Age range at start: 6‐14 years (average = 9).
 Surfaces affected at start: 3.9 DMFS.
 Background exposure to fluoride: water.
 Year study began: in/before 1963.
 Location: USA.
Interventions FT versus PL 
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Ca pyrophosphate.
Outcomes 3yDMFS increment ‐ cl+xr.
 Reported at 1, 2, 3, 4 and 5 years follow ups.
DMFT.
Notes Participants randomised (N = 500); numbers by group NR.
 Baseline characteristics (age, DMFS) 'balanced'.
 Clinical (VT) caries assessment by two examiners, diagnostic threshold = NR. Radiographic assessment (5‐7 BW); diagnostic threshold = NR. State of tooth eruption included = NR. Diagnostic errors NR.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure