Naylor 1979.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 20% drop out (for all study groups combined) after 3 years (study duration = 3 years). Natural losses; any differential group losses not assessable. | |
Participants | 625 children analysed at 3 years (available at final examination). Age range at start: 11‐12 years. Surfaces affected at start: 7.9 DFS. Background exposure to fluoride: none reported. Year study began: 1973. Location: UK. | |
Interventions | FT** versus PL
(SMFP group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Ca carbonate. |
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Outcomes | 3yDFS increment ‐ (E) (CA)cl+(ER)xr.
Reported at 3 years follow up. DFT. DFT (U). O‐BL‐DFS. MD‐DFS. CIR. |
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Notes | Participants randomised (numbers for relevant groups NR). Baseline characteristics (age, SAR, TAR, DFS, DFT) 'balanced'. Clinical (VT) caries assessment (FOTI used) by two examiners (independently); diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (2 postBW) by two examiners (independently); diagnostic threshold = ER. Results of one examiner chosen (findings consistent throughout) . **Ca glycerophosphate/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) | Unclear risk | B ‐ Unclear |