Rong 2003

Methods	Study design: cluster‐randomised controlled trial Conducted in: China Unit of randomisation: kindergarten Unit of analysis: children Setting: Miyun County, 100 km northeast of Beijing Funded by: Procter & Gamble provided 2 kinds of toothpaste for use in the study Duration of the study: 2 years
Participants	Inclusion criteria: not reported Exclusion criteria: not reported Age at baseline: 3 years N (controls baseline): 370 N (controls follow‐up): 256 N (interventions baseline): 361 N (interventions follow‐up): 258 Recruitment: randomly assigned to test/control group; children recruited through kindergartens; all 3‐year‐old children in selected kindergartens were recruited Gender Intervention: 47.1% male Control: 52.9% male
Interventions	Interventions Oral health education programme administered to teachers, parents and children Supervised twice‐daily brushing of teeth in kindergarten with fluoridated toothpaste Control: no type of treatment Duration of intervention: 2 years
Outcomes	Caries increment
Implementation related factors	Theoretical basis: not reported Resources for implementation: Procter & Gamble provided 2 kinds of toothpaste for use in the study Who delivered the intervention: dentist and teachers 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: not reported Economic evaluation: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly selected by drawing lots
Allocation concealment (selection bias)	Low risk	Toothpastes provided to experimental and the control groups were identical in taste, appearance and packaging, except that fluoride was included in the test toothpaste. Participants and examiners were not aware of the assignment of toothpastes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported
Other bias	Unclear risk	Unclear, but this study was funded by a commercial company, which could have resulted in other potential sources of bias
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and examiner were not aware of the assignment of toothpaste
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Examiner blindness to group assignment of children was maintained throughout the study