Di Maggio 1980.

Methods	Random allocation; double‐blind (A); placebo‐controlled; 16% drop out (for both study groups combined) after 2 years (study duration = 2 years). Main reason for attrition described: left institution; any differential group losses not assessable.
Participants	42 children analysed at 2 years (available at final examination). Age range at start: 11‐12 years. Surfaces affected at start: 11.7 DMFS. Background exposure to fluoride: data not obtained for fluoridation status of site. Year study began: in/before 1977. Location: Italy.
Interventions	FT versus PL (SMFP‐NaF group = 2500 ppm F). Institution use/supervised, three times a day. Abrasive system: not clearly specified.
Outcomes	2yDMFS increment ‐ cl. Reported at 1 and 2 years follow ups. DMFT.
Notes	Participants randomised (N = 50). Baseline characteristics (DMFS, DMFT) 'balanced'. Clinical caries assessment by two examiners; diagnostic threshold NR; state of tooth eruption included NR. Diagnostic errors NR.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear