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. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

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.
Outcomes 2yDMFS increment ‐ (CA)cl+(ER)xr.
 Reported at 2 years follow up.
Stain score.
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
HHS Vulnerability Disclosure