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

Peterson 1979.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 25% drop out after 2.5 years (study duration = 2.5 years). Natural losses; exclusions based on presence in all follow‐up examinations; any differential group losses not assessable.
Participants 712 children analysed at 2.5 years (present for all examinations).
 Age range at start: 8‐12 years (average = 10).
 Surfaces affected at start: 2.9 DFS.
 Background exposure to fluoride: water.
 Year study began: 1971.
 Location: USA.
Interventions FT (2 groups) versus PL 
 (both SMFP groups = 1000 ppm F).
School use/supervised, daily, (appropriate toothpastes also provided for home use).
 Abrasive system: Ca carbonate in one toothpaste and in placebo toothpaste, IMP in the other SMFP toothpaste.
Outcomes 2.5yDFS increment ‐ cl+xr.
 Reported at 2.5 years follow up.
DMFT.
 MD‐DFS.
Notes Participants randomised (N = 950); numbers by group NR.
 Baseline characteristics (DFS, MD‐DFS, DFT) 'balanced'.
 Clinical (VT) caries assessment (FOTI used) by one examiner; diagnostic threshold = CA; state of tooth eruption included NR; radiographic assessment (postBW) by one examiner; diagnostic threshold = ER. Diagnostic errors NR.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure