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

Howat 1978.

Methods Random allocation; double‐blind (A); placebo‐controlled; 12% drop out after 3 years (study duration = 3 years). Reasons for attrition described with respective total numbers (56 left school, 7 withdrawn by own choice, 2 lack of co‐operation); any differential group losses not assessable.
Participants 495 children analysed at 3 years (available at final examination).
 Age range at start: 11‐12 years. 
 Surfaces affected at start: 7.4 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: in/before 1974.
 Location: UK.
Interventions FT versus PL 
 (SMFP group = 1000 ppm F).
School use/supervised, daily, for 1 min (appropriate toothpastes also provided for home use).
 Abrasive system: silica zerogel.
Outcomes 3yNetDMFS increment ‐ (E) (CA)cl+(DR)xr.
 Reported at 3 years follow up.
antDMFS.
 postDMFS.
 PF‐DMFS.
 MD‐DMFS.
 MD‐BL‐DMFS.
 DMFT.
Notes Participants randomised (N = 560); numbers by group NR.
 Baseline characteristics (DMFS, DMFT, SAR) 'balanced'.
 Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included = E/U; radiographic assessment (2 postBW) by one examiner; diagnostic threshold = DR. Reproducibility checks done in 10% sample clinically and radiographically (icc of incremental data between 0.96 and 0.99).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure