Dolles 1980.
Methods | Stratified random allocation; double‐blind (A); placebo‐controlled; 22% natural drop out after 2 years (study duration = 2 years). Reasons for attrition described with numbers by group: unacceptable staining (3,4), unacceptable taste (2,0), change of residence (0,2), other reasons/lack of co‐operation(1,1); exclusions based on presence in all follow‐up examinations; no differential group losses. | |
Participants | 47 children analysed at 2 years (present for all examinations). Average age at start: 13 years. Surfaces affected at start: NR. Background exposure to fluoride: none. Year study began: 1974. Location: Norway. | |
Interventions | FT(Chlor) versus PL(Chlor) **
(NaF toothpaste = 500 ppm F). Home use/unsupervised, daily frequency assumed (instructed to brush for 2 min twice a day). Abrasive system: plastic particles. |
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Outcomes | 2yDS increment ‐ (CA)cl+(ER)xr.
Reported at 2 years follow up. Proportion of children with new carious surface. |
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Notes | Participants randomised (N = 60). Baseline characteristics NR. Clinical (VT) caries assessment, diagnostic threshold = CA; state of tooth eruption included NR. Radiographic assessment (postBW), diagnostic threshold = ER. Diagnostic errors NR. **Chlorhexidine present in both, the fluoride and the non‐fluoride toothpaste groups (other outcomes measured, such as tooth staining, not considered relevant for the comparison of interest). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |