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

Muhler 1970.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 15% drop out after 1 year (study duration = 1 year). Reasons for attrition NR; differential group losses.
Participants 436 children analysed at 1 year (available at final examination).
 Age range at start: 5‐16 years (average = 10).
 Surfaces affected at start: 10.3 DMFS. 
 Background exposure to fluoride: data not available for fluoridation status of site.
 Year study began: in/before 1967.
 Location: USA.
Interventions FT** versus PL 
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Ca pyrophosphate.
Outcomes 1yDMFS increment ‐ cl+xr.
 Reported at 6 m and 1 year follow ups.
DMFT.
Notes Participants randomised (N = 510).
 Baseline characteristics (age, gender, DMFS) with some imbalance.
 Clinical (VT) caries assessment by one examiner, diagnostic threshold = NR. Radiographic assessment (5‐7 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