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

Mainwaring 1978.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 18% drop out (for all study groups combined) after 3 years (study duration = 3 years). Natural losses; any differential group losses not assessable.
Participants 1107 children analysed at 3 years (available at final examination).
 Age range at start: 11‐12 years.
 Surfaces affected at start: 7.9 DFS.
 Background exposure to fluoride: none reported.
 Year study began: in/before 1974.
 Location: UK.
Interventions FT (2 groups) versus PL 
 (both SMFP groups = 1000 ppm F).
Home use/unsupervised, for 1 min, daily frequency assumed.
 Abrasive system: Ca carbonate in all toothpastes.
Outcomes 3yNetDFS increment ‐ (E)(CA)cl+(ER)xr.
 Reported at 3 years follow up.
PF‐DFS .
 postMD‐DFS. 
 CIR.
Notes Participants randomised (numbers for relevant groups NR).
 Baseline characteristics (age, SAR, DFS) 'balanced'.
 Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included = E. Radiographic assessment (2 postBW) by one examiner; diagnostic threshold = ER. Intra‐examiner reproducibility checks for DFS in 10% sample (icc for VT/XR over 0.95); error variance less than 5% of total variance; reversal rate less than 5% of observed DFS increment in all groups.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure