Koch 1967b.
Methods | Stratified random allocation***; double‐blind (A); placebo‐controlled; 19% drop out after 2 years (study duration = 2 years). Natural losses; any differential group losses not assessable. | |
Participants | 70 children analysed at 2 years (present for entire trial period). Age range at start: 13‐14 years. Surfaces affected at start: 30.1 DFS. Background exposure to fluoride: none reported. Year study began: 1963. Location: Sweden. | |
Interventions | FT versus PL
(NaF group = 1000 ppm F). Home use/unsupervised, twice a day instructed frequency but daily frequency assumed, for 2 min. Abrasive system: methacrylate polymer (acrylic). |
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Outcomes | 2yDFS increment ‐ cl(CA)(E).
Reported at 2 years follow up. DFT. O‐DFS. MD‐DFS. BL‐DFS. Annual CAR. Secondary caries. |
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Notes | Participants randomised (N = 86); numbers by group NR. 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 |