Ran 1991.
Methods | Random allocation; double‐blind (A); placebo‐controlled; 20% drop out (for all study groups combined) after 1.5 years (study duration = 1.5 years + 0.5 year post‐intervention period). Reasons for attrition/handling of exclusions NR; any differential group losses not assessable. | |
Participants | 55 children analysed at 1.5 years; all male. Average age at start: 13 years. Surfaces affected at start: 6.4 DMFS. Background exposure to other fluoride: data not obtained for home use of toothpaste. Year study began: in/before 1989. Location: Israel. | |
Interventions | FT versus PL
(AmF group = 1250 ppm F). School use/supervised, fortnightly/20 times a year, 1g applied for 4 minutes, no post‐brushing rinse done (no provision of any toothpaste reported for home use). Abrasive system: NR. |
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Outcomes | 1.5yNetDMFS increment ‐ (CA). Reported at 0.5 and 1.5 years follow ups (and 0.5 year post‐treatment). | |
Notes | Participants randomised (numbers for relevant groups NR). Baseline characteristics (DMFS) with some imbalance (reported as NS difference). Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included NR. Intra‐examiner reproducibility checks for DMFS (icc reaching 0.97). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |