Fanning 1968.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 22% natural drop out after 2 years (study duration = 2 years); no differential group losses (46% drop out based on analysis performed for randomised block design). | |
Participants | 844 children analysed at 2 years (422 complete replicates of each group available). Age range at start: 12‐14 years (average = 13). Surfaces affected at start: 17.7 DMFS (from sample randomised). Background exposure to fluoride: none. Year study began: 1964. Location: Australia. | |
Interventions | FT** versus PL
(SnF2 group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: IMP. |
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Outcomes | 2yDMFS increment ‐ (CA)cl+(ER)xr.
Reported at 2 years follow up. Stain score. |
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Notes | Participants randomised (N = 1576). Baseline characteristics (DMFS, DMFT, SAR) 'balanced'. Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA. Radiographic assessment (5 BW) by two examiners; diagnostic threshold = ER. State of tooth eruption included = E/U. Intra‐ and inter‐examiner reproducibility of clinical caries diagnosis (DFS) assessed annually by duplicate examination of 10% random sample ("error relatively small, NS difference between or within examiners"). **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) | Unclear risk | B ‐ Unclear |