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

Cahen 1982.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 20% drop out after 3 years (study duration = 3 years). Natural losses and exclusions based on presence in all follow‐up examinations; any differential group losses not assessable.
Participants 2008 children analysed at 3 years (present for all examinations).
 Age range at start: 6‐8 years (average = 7).
 Surfaces affected at start: 1.4 DMFS (control group only).
 Background exposure to fluoride: data not obtained for fluoridation status of site.
 Year study began: 1977.
 Location: France.
Interventions FT (2 groups) versus PL 
 (SMFP group = 1500 ppm F, AmF group = 1500 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: IMP in the SMFP and placebo toothpaste, Ca carbonate/ Na and Al silicates in the AmF toothpaste.
Outcomes 3yDMFS increment ‐ cl+xr.
 Reported at 3 years follow up.
DMFT.
df‐rate.
Notes Participants randomised (N = 2500); numbers by group NR.
 Baseline characteristics (age, gender) 'balanced'.
 Clinical (V) caries assessment by six examiners; diagnostic threshold = NR; state of tooth eruption included NR. Radiographic assessment (2 postBW) by one examiner; diagnostic threshold NR; partial recording. Inter‐ and intra‐examiner reproducibility of clinical and radiographic caries diagnosis assessed in 10% sample ("good reproducibility, NS difference between or within examiners").
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure