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

Muhler 1955.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 22% drop out after 1 year (study duration = 1 year). Reasons for attrition NR; differential group losses.
Participants 444 children analysed at 1 year (available at final examination).
 Age range at start: 6‐16 years. Surfaces affected at start: 9.3 DMFS.
 Background exposure to fluoride: data not available for fluoridation status of site.
 Year study began: in/before 1954.
 Location: USA.
Interventions FT** versus PL 
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: heat‐treated Ca orthophosphate.
Outcomes 1yDMFS increment ‐ cl+xr.
 Reported at 6 m and 1 year follow ups.
DMFT.
Notes Participants randomised (N = 568).
 Baseline characteristics (DMFS) 'balanced'.
 Clinical (VT) caries assessment by one examiner, diagnostic threshold = NR. Radiographic assessment by one examiner; diagnostic threshold = NR. State of tooth eruption included = NR. Criteria for caries diagnosis reported to have been carefully standardised, diagnostic errors NR.
 **NaF‐heat treated Ca orthophosphate toothpaste group not considered (abrasive system known to be incompatible with NaF).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure