Held 1968b.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 62% drop out after 2 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 | 32 children analysed at 2* years (available at final examination). Average age at start: 15 years. Surfaces affected at start: 10.2 DMFS. Background exposure to fluoride: data not available for fluoridation status of site. Year study began: 1961. Location: France. | |
Interventions | FT versus PL
(NaF group = 500 ppm F). Institution use/supervised, twice a day. Abrasive system: not clearly specified (silica used). |
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Outcomes | 2y*DMFS increment ‐ (E) cl.
Reported at 2 and 3 years follow ups. DMFT. Annual CAR. |
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Notes | Participants randomised (N = 85). 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. *Results for 3 years follow up not considered due to very high drop out rate. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |