James 1977.

Methods	Stratified random allocation; double‐blind (A); placebo‐controlled; 19% drop out after 3 years (study duration = 3 years). Reasons for attrition NR; exclusions based on presence in all follow‐up examinations; any differential group losses not assessable.
Participants	782 children analysed at 3 years (present for all examinations). Age range at start: 11‐12 years. Surfaces affected at start: 11.2 DMFS. Background exposure to fluoride: data not available for fluoridation status of site. Year study began: 1970. Location: UK.
Interventions	FT versus PL (SMFP group = 2400 ppm F). Home use/unsupervised, daily frequency assumed. Abrasive system: Al oxide trihydrate.
Outcomes	3yDMFS increment ‐ (CA)cl+(ER)xr. Reported at 3 years follow up. postMD‐DMFS. O‐DMFS. BL‐DMFS. O‐BL‐MDDMFS. antDMFS.
Notes	Participants randomised (N = 964); numbers by group NR. Baseline characteristics (age, gender, DMFS) 'balanced'. Clinical (VT) caries assessment by two examiners; diagnostic threshold = CA; radiographic assessment (2 postBW); state of tooth eruption included NR. Inter‐ and intra‐ examiner reliability for clinical and radiographic diagnosis revealed by re‐examination of 10% sample.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear