Kleber 1996.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 10% drop out after 1 year (study duration = 1 year). Main reasons for attrition: changes in residence, few exclusions for initiation of ortho treatment; no differential group losses. | |
Participants | 156 children analysed at 1 year (available at final examination). Age range at start: 10‐11 years (average = 10.7). Surfaces affected at start: 4.2 DMFS. Background exposure to fluoride: none reported. Year study began: in/before 1994. Location: USA. | |
Interventions | FT(+Alrins) versus PL(+Alrins) **
(NaF toothpaste = 1100 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: silica. |
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Outcomes | 1yDMFS increment ‐ (CA)cl+(ER)xr.
Reported at 0.6 and 1 year follow ups. DMFT. Proportion of children remaining caries‐free. Proportion of children with new DMFS. Oral soft tissues lesions. |
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Notes | Participants randomised (N = 174). Baseline characteristics (age, gender DMFS, DMFT) 'balanced'. Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (postBW) by two examiners (independently); diagnostic threshold = ER. Reversals were small in both groups and equally common. Results of one examiner chosen (findings consistent throughout). **Rinsing with 500 ppm Al solutions performed daily at school in both relevant groups compared. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |