Zacherl 1973.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 34% drop out after 2 years (study duration = 2 years). Reasons for attrition NR; no differential group losses. | |
Participants | 444 children analysed at 2 years (available at final examination). Age range at start: 5‐12 years (average = 9). Surfaces affected at start: 8.5 DMFS. Background exposure to fluoride: none reported. Year study began: in/before 1970. Location: USA. | |
Interventions | FT** versus PL
(SnF2 group = 1000 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Ca pyrophosphate in SnF2 toothpaste, placebo toothpaste abrasive NR. |
|
Outcomes | 2yDMFS increment ‐ cl+xr.
Reported at 1 and 2 years follow ups. DMFT. |
|
Notes | Participants randomised (N = 677). Baseline characteristics (age, DMFS, DMFT) 'balanced'. Clinical (VT) caries assessment by one examiner, diagnostic threshold = NR. Radiographic assessment (5‐10 BW) by one examiner; diagnostic threshold = NR. State of tooth eruption included = NR. Diagnostic errors NR. **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 |