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

Zacherl 1970a.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 35% drop out after 2.5 years (study duration = 2.5 years). Reasons for attrition NR; no differential group losses.
Participants 528 children analysed at 2.5 years (available at final examination).
 Age range at start: 13‐14 years. Surfaces affected at start: 23.5 DMFS. 
 Background exposure to fluoride: none reported.
 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 2.5yDMFS increment ‐ cl+xr.
 Reported at 10 m, 1.5 and 2.5 years follow ups.
DMFT.
Notes Participants randomised (N = 811).
 Baseline characteristics (dental age, gender, DMFS, DMFT, oral hygiene) 'balanced'.
 Clinical (VT) caries assessment by one examiner, diagnostic threshold = NR. Radiographic assessment (5‐10 BW) by one examiner; 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) High risk C ‐ Inadequate
HHS Vulnerability Disclosure