Naylor 1967.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 17% drop out (for all study groups combined) after 3 years (study duration = 3 years). Natural losses; any differential group losses not assessable. | |
Participants | 973 children analysed at 3 years (available at final examination). Age range at start: 11‐12 years. Surfaces affected at start: 9.5 DMFS. Background exposure to fluoride: none reported. Year study began: 1961. Location: UK. | |
Interventions | FT** versus PL
(SnF2 group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: IMP (main abrasive) in fluoride toothpaste, dicalcium phosphate (dihydrate) in placebo toothpaste. |
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Outcomes | 3ycrudeDFS increment ‐ (E+U) (CA)cl+(ER)xr.
Reported at 3 years follow up. DMFT. DMFS. postMD‐DFS. 1stmoMD‐DFS. Proportion of children with tooth staining. |
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Notes | Participants randomised (numbers for relevant groups NR). Baseline characteristics (age, gender, SAR, DMFS, DMFT, postMD‐DFS) 'balanced'. Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (2 postBW) by one examiner; diagnostic threshold = ER. Reversal rate less than 4% of observed DFS increment in all groups. High accuracy of diagnosis revealed by 10% sample checks (clinically and radiographically). **Na N‐lauroyl sarcosinate/SMFP toothpaste group not considered (additional non‐F active agent used in this group only). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |