Koch 1967c.
Methods | Stratified random allocation***; double‐blind (A); placebo‐controlled; 19% drop out after 3 years (study duration = 3 years). Natural losses; no differential group losses. | |
Participants | 255 children analysed at 3 years (present for entire trial period). Age range at start: 7‐10 years. Surfaces affected at start: 7.9 DFS. Background exposure to fluoride: none reported. Year study began: 1962. Location: Sweden. | |
Interventions | FT versus PL
(NaF group = 1000 ppm F). School clinic/supervised, 3 times a year, 1g applied for 2 min (no provision of any toothpaste reported for home use). Abrasive system: methacrylate polymer (acrylic). |
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Outcomes | 3yDFS increment ‐ cl(CA)(E).
Reported at 1 and 3 years follow ups. DFT. Annual CAR. Secondary caries. |
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Notes | Participants randomised (N = 316). Baseline characteristics (FS, FT, SAR, TAR) 'balanced'. Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; radiographic assessment (2 postBW) used as an aid but not reported; state of tooth eruption included = E. Diagnostic errors NR. *** Allocation concealment considered adequate by consensus. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |