Monse 2013

Methods	Study design: controlled before‐and‐after Conducted in: Philippines Unit of randomisation: school Unit of analysis: individual Setting: elementary schools Funded by: "The Fit for School Health Outcome Study in the Philippines is financed through the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH" Duration of the study: 1 year
Participants	Inclusion criteria: Public elementary schools were selected on the basis of Location along a highway or no more than 1 km from a highway No problems related to law and order in the surrounding community Exclusion criteria: children with systemic medical conditions and other chronic infectious diseases, such as tuberculosis Age at baseline: 6 to 7 years N (controls baseline): 173 N (controls follow‐up): 173 N (interventions baseline): 168 N (interventions follow‐up): 168 Recruitment: Participants were recruited from 4 randomly selected public elementary schools that were randomly assigned to study groups Gender Intervention: male = 52.0% Control: male = 47.1%
Interventions	Intervention: Essential Health Care Programme (EHCP11), which included the following: daily supervised handwashing with soap and clean water (as a scheduled group activity), daily supervised brushing with a fluoride toothpaste (0.3 mL; 1450 ppm free available fluoride, scheduled group activity) and biannual deworming with a single dose of albendazole (400 mg) as a mass drug administration at school. Daily supervised toothbrushing with fluoride toothpaste (0.03 mL; 1450 ppm) Control: standard health education programme as defined by the Department of Education. It consists of an annual physical examination, biannual deworming carried out by school nurses, the distribution of a single (10 mL) commercial toothpaste sachet, a toothbrush, an oral health message at the beginning of the school year and health education as part of the regular school curriculum Duration of intervention: 1 year
Outcomes	Caries (DMFS12)
Implementation related factors	Theoretical basis: Fit for School Action Framework, which outlines principles of simplicity, scalability and sustainability Resources for implementation: not reported Who delivered the intervention: research staff and dentists PROGRESS categories assessed at baseline: gender 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)	Unclear risk	Unclear
Allocation concealment (selection bias)	Unclear risk	Unclear
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear
Selective reporting (reporting bias)	Unclear risk	Unclear
Other bias	Unclear risk	Unclear
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All examiners were blinded to different groups
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear