Zanin 2007.

Methods	Study design: Randomised controlled trial (2 arms) Conducted in: South America, Brazil Unit of randomisation: Individual Unit of analysis: Individual Funded by: Not stated
Participants	Inclusion criteria: Children were screened in order to only include those at high risk of caries in the study Exclusion criteria: Children suffering from fluorosis, hypoplasia, systemic alteration or who had fixed braces were excluded Age at baseline: Mean age 6 years Gender: Not reported Number of participants randomised: Intervention n = 30, Control n = 30 Number of participants evaluated: Intervention n = 30, Control n = 30
Interventions	Comparison: Intensive education programme and individual supervised brushing versus once yearly supervised brushing and topical fluoride application Intervention: Interventions every 3 months for the 15 months of the study educational programme including group work (active learning). Age specific technique for brushing was taught in order to maximize manual removal of accumulated plaque deposits. During the first month, oral health education sessions were delivered as 4, 30 minute lectures. The sessions were delivered to small groups (n = 10) of children and involved elements of active learning. It was not clear who delivered the intervention. These sessions included general information regarding physiology of the mouth, function and disease, identification of cariogenic foods, influence on plaque formation and education about the behaviour health link and oral health habits. An age specific skills technique for brushing was taught in order to maximize manual removal of accumulated plaque deposits. Every 3 months after these children received supervised brushing sessions with reinforcement of oral health promotion concepts. No links to parents or the home were made Control: 1 annual supervised toothbrushing and dental hygienist applied topical fluoride Duration of intervention: 15 months Post‐intervention: 3 months, 6 months, 9 months, 12 months, 15 months Duration of follow‐up: None Behavioural or psychological component: Modelling, instruction in method, behaviour‐health link Dental: General information including physiology, function and disease. Education about the behaviour health link. Skills for toothbrushing via instruction and supervised practice Nutrition: Identification of cariogenic foods
Outcomes	Caries: dmfs/DMFS (prevalence) Plaque: Silness and Löe (median values)
Notes	Design by/Pilot work: Unclear how the intervention was designed and if any pilot work was conducted Power calculation: "Estimated sample size was based on an expected mean difference of 0.3 between groups with a standard deviation of 0.3. Assuming a power of 0.8 the sample size was 15 children in each group" (p 246)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Raffle made to allocate volunteers randomly to control and experimental groups" (p 247)
Allocation concealment (selection bias)	Unclear risk	Paper does not state who conducted the allocation raffle and whether it was concealed from investigators
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind trial. However it is unclear how participants could be unaware of their allocated treatment group
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐blind trial (2 assessors both blinded to intervention allocation)
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomised participants included in outcome evaluation
Selective reporting (reporting bias)	Low risk	Published report presents all expected outcomes of interest to the review
Other bias	Low risk	No other sources of bias identified

¹ BCTs = behaviour change techniques