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

Reed 1975.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 39% drop out after 2 years (study duration = 2 years). Reasons for high drop out not described; no differential group losses.
Participants 344 children analysed at 2 years (available at final examination).
 Age range at start: 8‐13 years (average = 10).
 Surfaces affected at start: 5 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: in/before 1968.
 Location: USA.
Interventions FT versus PL
 (NaF group = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Ca pyrophosphate.
Outcomes 2yDMFS increment ‐ cl+xr.
 Reported at 1 and 2 years follow ups.
DMFT.
Notes Participants randomised (N = 567).
 Baseline characteristics (age, gender, DMFS, DMFT) with some imbalance.
 Clinical (VT) caries assessment by one examiner; diagnostic threshold NR; state of tooth eruption included NR. Radiographic assessment (up to 7 BW) by one examiner; diagnostic threshold NR. Diagnostic errors NR.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure