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

Zacherl 1973.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 34% drop out after 2 years (study duration = 2 years). Reasons for attrition NR; no differential group losses.
Participants 444 children analysed at 2 years (available at final examination).
 Age range at start: 5‐12 years (average = 9).
 Surfaces affected at start: 8.5 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: in/before 1970.
 Location: USA.
Interventions FT** versus PL 
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Ca pyrophosphate in SnF2 toothpaste, placebo toothpaste abrasive NR.
Outcomes 2yDMFS increment ‐ cl+xr.
 Reported at 1 and 2 years follow ups.
DMFT.
Notes Participants randomised (N = 677).
 Baseline characteristics (age, DMFS, DMFT) '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.
 **Na N‐lauroyl sarcosinate/SMFP toothpaste group not considered (additional non‐F active agent used in this group only).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure