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

Fogels 1979.

Methods Random allocation; double‐blind (A); placebo‐controlled; 40% drop out after 3 years (study duration = 3 years). Reasons for attrition described: graduations, change of residence/school, parental requests, and ortho treatment; no differential group losses.
Participants 1339 children analysed at 3 years (available at final examination).
 Age range at start: 6‐11 years (average = 9).
 Surfaces affected at start: 4.9 DFS. Background exposure to fluoride: none reported. 
 Year study began: 1972.
 Location: USA.
Interventions FT (2 groups) versus PL 
 (both SnF2 groups = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: silica gel in one SnF2 and placebo toothpaste, Ca pyrophosphate in the other.
Outcomes 3yNetDFS increment ‐ (CA)cl+(ER)xr.
 Reported at 3 years follow up.
MD‐DFS.
 DFS (U).
 DMFT.
Oral soft tissues lesions (data NR).
Proportion of children with tooth staining (data NR).
Notes Participants randomised (N = 2218).
 Baseline characteristics (DFS) 'balanced'.
 Clinical (VT) caries assessment by two examiners, diagnostic threshold = CA. Radiographic assessment (postBW) by two examiners; diagnostic threshold = ER. State of tooth eruption included E/U. Results shown for each examiner and for the pooled data from both (F‐ratios less than unit for examiner by treatment interactions); combined results considered.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure