Hochstetter 2007

Methods	Study design: randomised controlled trial Conducted in: Argentina Unit of randomisation: individual Unit of analysis: individual Setting: Buenos Aires Funded by: not disclosed or reported Duration of the study: 1 year
Participants	Inclusion criteria Parent’s commitment to comply with the programme and participate in all activities Children in good general/systemic health No antibiotics or medications affecting salivary glands within 3 months before the study Exclusion criteria: not reported Age at baseline: 4.17 ± 0.27 years Total at baseline: 58 N (controls baseline): 29 N (controls follow‐up): 29 N (interventions baseline): 29 N (interventions follow‐up): 29 Recruitment: selected a state school in Buenos Aires serving children at social risk Gender: not reported
Interventions	Intervention: preventive‐educational programme for parents, teachers and children Educational programme for parents aimed at increasing awareness of children’s dental health and supervision of child’s daily oral hygiene Educational programme for teachers aimed at developing their skills to supervise oral hygiene of children in the experimental group Educational programme for children aimed at developing self care behaviours and education on the mouth, plaque‐associated disease and plaque prevention. Application of acidulated sodium fluoride phosphate. Daily supervised toothbrushing using toothpaste containing 0.12% sodium fluoride Control: preventive programme of application of acidulated sodium fluoride phosphate. Daily supervised toothbrushing with toothpaste containing 0.12% sodium fluoride Duration of intervention: unclear
Outcomes	Caries increment, gingival and index
Implementation related factors	Theoretical basis: life course, social determinants of health, socio‐ecological model and health promotion Resources for implementation: educational materials for programme, training and trainer, fluoride varnish, toothpaste and toothbrushes, dentist Who delivered the intervention: dentists PROGRESS categories assessed at baseline: not reported PROGRESS categories analysed at outcome: not reported Outcomes related to harms/unintended effects: not reported Intervention included strategies to address diversity or disadvantage: selected a state school serving children at social risk Economic evaluation: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The school was selected on the basis of including children at social risk. No mention of how random generation of participants was conducted
Allocation concealment (selection bias)	Unclear risk	No mention of how participants were allocated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear
Selective reporting (reporting bias)	Unclear risk	All outcome data are reported as means and confidence intervals on a graph that has errors in labelling of control and experimental groups
Other bias	Unclear risk	Control and experimental groups went to the same school
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unclear
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Examiners were blinded