Haleem 2012

Methods	Study design: cluster‐randomised controlled trial Conducted in: Karachi, Pakistan Unit of randomisation: school Unit of analysis: individual Setting: private and public schools Funded by: "The preventive oral health care project for secondary school children, of which the present trial formed an evaluative component, was funded by the World Health Organization/Government of Pakistan Collaborative Program ‐ Oral Health Component through Shaikh Zayed Medical Complex (Pakistan)" Duration of the study: 2 years
Participants	Inclusion criteria: all public and private schools with ≥ 1 section of class 6 and not fewer than 35 students per section in the cosmopolitan city of Karachi. Schools were eligible to participate if they were located in towns with socio‐economic and ethnic homogeneity Exclusion criteria: not reported Age at baseline: 10 to 11 years N (controls baseline): 8 schools, 324 children N (controls follow‐up): 8 schools, 290 children N (dentist‐led baseline): 8 schools, 333 children N (dentist‐led follow‐up) :8 schools, 303 children N (teacher‐led baseline): 8 schools, 333 children N (teacher‐led follow‐up): 8 schools, 307 children N (peer‐led baseline): 8 schools, 341 children N (peer‐led follow‐up): 8 schools, 325 children N (self learning baseline): 8 schools, 326 children N (self learning follow‐up): 8 schools, 292 children Recruitment: All public and private schools with ≥ 1 section of class 6 and not fewer than 35 students per section in the cosmopolitan city of Karachi were eligible to participate Gender: not reported
Interventions	Oral health education was delivered to 4 groups distinguished by the person who delivered the intervention. These groups were dentist‐led, teacher‐led, peer‐led and self learning. One hour of oral health education included education on functional and psychosocial roles of healthy teeth, anatomy of the teeth, dietary education and daily brushing with fluoridated toothpaste and demonstration of toothbrushing Control: received no oral health education Duration of intervention: 1‐hour session
Outcomes	Periodontal health
Implementation related factors	Theoretical basis: social‐cognitive theory Resources for implementation: not reported Who delivered the intervention: dentists, teachers, peer and self 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	Lottery method was used to allocate schools to respective groups
Allocation concealment (selection bias)	Low risk	All clusters were randomised at once
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rate was low (< 10%)
Selective reporting (reporting bias)	Unclear risk	Unclear
Other bias	Unclear risk	Unclear
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Dentist and dental assistant who conducted oral examination and structured interview, respectively, were kept blinded to group allocation of study participants right from baseline until the end of the study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Schools were assigned numbers and alphabets to conceal the allocated school from outcome assessors and the data management team