Held 1968a.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 64% drop out after 3 years (study duration = 3 years). Reasons for high drop out due to age range at which many leave the institutions; no differential group losses. | |
Participants | 36 children analysed at 3 years (available at final examination). Age range at start: 15‐16 years. Surfaces affected at start: 9.6 DMFS. Background exposure to fluoride: data not available for fluoridation status of site. Year study began: 1961. Location: France. | |
Interventions | FT versus PL
(NaF‐SnF2 group = 1000 ppm F). Institution use/supervised, twice a day. Abrasive system: not clearly specified (silica used). |
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Outcomes | 3yDMFS increment ‐ (E) cl.
Reported at 3 years follow up. DMFT. Annual CAR. |
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Notes | Participants randomised (N = 101). Baseline characteristics (DMFS, DMFT) not balanced. Clinical (VT) caries assessment by one examiner; diagnostic threshold NR; state of tooth eruption included = E. Intra‐examiner reproducibility checks done. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |