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

Hanachowicz 1984.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 28% drop out after 3 years (study duration = 3 years). Natural losses and exclusions based on compliance; no differential group losses.
Participants 945 children analysed at 3 years (available at final examination and cooperative).
 Age range at start: 10‐12 years. 
 Surfaces affected at start: 5.4 DMFS.
 Background exposure to fluoride: none reported.
 Year study began: 1979.
 Location: France.
Interventions FT versus PL 
 (SMFP group = 1500 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: Al oxide trihydrate.
Outcomes 3yNetDMFS increment ‐ (E)(CA)cl+xr.
 Reported at 3 years follow up.
DMFT.
 DMFS (U).
 O‐DMFS.
 MD‐DMFS.
 BL‐DMFS.
 premolarDMFT.
 premolarDMFS.
Proportion of children with new caries.
Notes Participants randomised (N = 1318).
 Baseline characteristics (DMFS) 'balanced'.
 Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA; radiographic assessment (2 postBW) by one examiner; diagnostic threshold NR. State of tooth eruption included = E/U. Consistency of clinical and x‐ray diagnosis assessed by duplicate examinations of 6% sample (inter‐examiner reproducibility ratios 0.24 for clinical and 0.13 for x‐ray; intra‐examiner reproducibility 0.27 for clinical and 0.14 for x‐ray).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure