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

Glass 1978.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 35% drop out after 3 years (study duration = 3 years). Natural losses, increased during 3rd year because an entire grade graduated; exclusions based on presence in all follow‐up examinations; any differential group losses not assessable.
Participants 346 children analysed at 3 years (present for all examinations).
 Age range at start: 6‐11 years (average = 9).
 Surfaces affected at start: 4.1 DFS.
 Background exposure to fluoride: none reported.
 Year study began: in/before 1974.
 Location: USA.
Interventions FT versus PL 
 (SMFP group = 1000 ppm F).
School use/supervised, 1g applied daily (appropriate toothpastes and toothbrushes also provided for home use).
 Abrasive system: Ca carbonate.
Outcomes 3yNetDFS increment ‐ (CA)cl+(ER)xr.
 Reported at 1, 2 and 3 years follow ups.
MD‐DFS.
 O‐BL‐DFS.
 DFT.
CIR.
 O‐BL‐CIR.
 MD‐CIR.
Notes Participants randomised (N = 533); numbers by group NR.
 Baseline characteristics (age, DFS, DFT, SAR, TAR) 'balanced'.
 Clinical (VT) caries assessment (FOTI used) by one examiner; diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (2 postBW) by one examiner; diagnostic threshold = ER. Reversals were small in both groups (about 6% of DFS increments) and equally common (NS different).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk D ‐ Not used
HHS Vulnerability Disclosure