Hanachowicz 1984.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 28% drop out after 3 years (study duration = 3 years). Natural losses and exclusions based on compliance; no differential group losses. | |
Participants | 945 children analysed at 3 years (available at final examination and cooperative). Age range at start: 10‐12 years. Surfaces affected at start: 5.4 DMFS. Background exposure to fluoride: none reported. Year study began: 1979. Location: France. | |
Interventions | FT versus PL
(SMFP group = 1500 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Al oxide trihydrate. |
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Outcomes | 3yNetDMFS increment ‐ (E)(CA)cl+xr.
Reported at 3 years follow up. DMFT. DMFS (U). O‐DMFS. MD‐DMFS. BL‐DMFS. premolarDMFT. premolarDMFS. Proportion of children with new caries. |
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Notes | Participants randomised (N = 1318). Baseline characteristics (DMFS) 'balanced'. Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA; radiographic assessment (2 postBW) by one examiner; diagnostic threshold NR. State of tooth eruption included = E/U. Consistency of clinical and x‐ray diagnosis assessed by duplicate examinations of 6% sample (inter‐examiner reproducibility ratios 0.24 for clinical and 0.13 for x‐ray; intra‐examiner reproducibility 0.27 for clinical and 0.14 for x‐ray). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |