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

Held 1968b.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 62% drop out after 2 years (study duration = 3 years). Reasons for high drop out due to age range at which many leave the institutions; no differential group losses.
Participants 32 children analysed at 2* years (available at final examination).
 Average age at start: 15 years.
 Surfaces affected at start: 10.2 DMFS.
 Background exposure to fluoride: data not available for fluoridation status of site.
 Year study began: 1961.
 Location: France.
Interventions FT versus PL 
 (NaF group = 500 ppm F).
Institution use/supervised, twice a day.
 Abrasive system: not clearly specified (silica used).
Outcomes 2y*DMFS increment ‐ (E) cl.
 Reported at 2 and 3 years follow ups.
DMFT.
 Annual CAR.
Notes Participants randomised (N = 85).
 Baseline characteristics (DMFS, DMFT) not balanced.
 Clinical (VT) caries assessment by one examiner; diagnostic threshold NR; state of tooth eruption included = E. Intra‐examiner reproducibility checks done.
 *Results for 3 years follow up not considered due to very high drop out rate.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure