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

Ran 1991.

Methods Random allocation; double‐blind (A); placebo‐controlled; 20% drop out (for all study groups combined) after 1.5 years (study duration = 1.5 years + 0.5 year post‐intervention period). Reasons for attrition/handling of exclusions NR; any differential group losses not assessable.
Participants 55 children analysed at 1.5 years; all male.
 Average age at start: 13 years.
 Surfaces affected at start: 6.4 DMFS.
 Background exposure to other fluoride: data not obtained for home use of toothpaste.
 Year study began: in/before 1989.
 Location: Israel.
Interventions FT versus PL 
 (AmF group = 1250 ppm F).
School use/supervised, fortnightly/20 times a year,
 1g applied for 4 minutes, no post‐brushing rinse done (no provision of any toothpaste reported for home use).
 Abrasive system: NR.
Outcomes 1.5yNetDMFS increment ‐ (CA).
 Reported at 0.5 and 1.5 years follow ups (and 0.5 year post‐treatment).
Notes Participants randomised (numbers for relevant groups NR).
 Baseline characteristics (DMFS) with some imbalance (reported as NS difference). Clinical (VT) caries assessment by one examiner; diagnostic threshold = CA; state of tooth eruption included NR. Intra‐examiner reproducibility checks for DMFS (icc reaching 0.97).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure