Andlaw 1975.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 13% drop out after 3 years (study duration = 3 years). Main reasons for attrition described: moved away, absent at final examination; no differential group losses. | |
Participants | 740 children analysed at 3 years (available at final examination). Age range at start: 11‐12 years. Surfaces affected at start: 6.9 DFS. Background exposure to fluoride: none reported. Year study began: 1970. Location: UK. | |
Interventions | FT versus PL
(SMFP group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Al oxide trihydrate. |
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Outcomes | 3yNetDFS increment ‐ (E+U)(CA)cl+(ER)xr.
Reported at 3 years follow up. DMFS. DFT. DMFT. PF‐DMFS. MD‐BL‐DMFS. MD‐DMFS. O‐DMFS. ECSI. |
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Notes | Participants randomised (N = 846). Baseline characteristics (age, dental age, TAR, DFS, DMFS, DFT, DMFT, ECSI) 'balanced'. Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA. Radiographic assessment (2 postBW) by two examiners; diagnostic threshold = ER. State of tooth eruption included = E/U. Reproducibility ratio was less than 0.22 for intra‐examiner reproducibility of clinical and radiographic caries diagnosis; "significant differences between examiners could not have affected caries increment figures since each examined same children annually". | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |