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

Horowitz 1966.

Methods Quasi‐random allocation; double‐blind (A); placebo‐controlled; 40% drop‐out rate after 3 years (study duration = 3 years). Natural losses; no differential group losses.
Participants 638 children analysed at 3 years (available at final examination).
 Age range at start: 6‐10 years.
 Surfaces affected at start: 2.08 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: 1961.
 Location: USA.
Interventions FT versus PL **
 (SnF2 group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Ca pyrophosphate.
Outcomes 3yNetDMFS increment ‐ (E+U) (CA)cl.
 Reported at 1, 2, and 3 years follow ups.
DMFT.
Notes Participants randomised (N = 1059).
 Baseline characteristics (DMFS, DMFT, TAR) 'balanced'.
 Clinical (VT) caries assessment by three examiners; diagnostic threshold = CA; state of tooth eruption included = E/U. Reversals were small in both groups (about 3% of DMFS increments) and equally common (NS different).
 ** Only relevant comparison (others were not
 randomised/quasi‐randomized)
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) High risk C ‐ Inadequate
HHS Vulnerability Disclosure