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

Hodge 1980.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 18% drop out after 3 years (study duration = 3 years). Reasons for attrition described with respective total numbers: 158 left school, 14 withdrawn by own choice, 8 lack of co‐operation; any differential group losses not assessable.
Participants 799 children analysed at 3 years (available at final examination).
 Age range at start: 11‐12 years. 
 Surfaces affected at start: 7.3 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: in/before 1976.
 Location: UK.
Interventions FT (3 groups) versus PL 
 (SMFP group = 1000 ppm F, both SMFP‐NaF groups = 1450 ppm F).
School use/supervised, daily, for 1 min (appropriate toothpastes also provided for home use).
 Abrasive system: alumina (in placebo toothpaste, SMFP and in one SMFP‐NaF toothpaste), dicalcium phosphate (in another SMFP‐NaF toothpaste).
Outcomes 3yNetDFS increment ‐ (E) (CA)cl+(DR)xr.
 Reported at 3 years follow up.
DMFT.
Notes Participants randomised (N = 979); numbers by group NR.
 Baseline characteristics (DMFS, DMFT, SAR) 'balanced' (DFS baseline data NR).
 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 0.92 and 0.97).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure