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. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

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.
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.
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
HHS Vulnerability Disclosure