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

Mergele 1968.

Methods Stratified random allocation; double‐blind ('A'); placebo‐controlled; 22% drop out (for all study groups combined) after 3 years (study duration = 3 years). Reasons for attrition: natural losses to follow up; any differential group losses not assessable.
Participants 387 children analysed at 3 years (available at final examination).
 Age range at start: 10‐13 years (average = 11).
 Surfaces affected at start: 6.5 DMFS.
 Background exposure to fluoride: water.
 Year study began: in/before 1964.
 Location: USA.
Interventions FT** versus 'PL' 
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Ca pyrophosphate in fluoride toothpaste, IMP in control toothpaste.
Outcomes 3yNetDMFS increment ‐ cl.
 Reported at 3 years follow up.
DMFT.
Notes Participants randomised (numbers for relevant groups NR).
 Baseline characteristics (age, SAR, DMFS, DMFT) 'balanced'.
 Clinical (VT) caries assessment by one examiner, diagnostic threshold = NR. State of tooth eruption included = NR. Diagnostic errors NR.
 **Na N‐lauroyl sarcosinate/SMFP toothpaste groups 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