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. 2016 Sep 15;2016(9):CD009837. doi: 10.1002/14651858.CD009837.pub2

Freitas‐Fernandes 2002

Methods Study design: controlled before‐and‐after study
Conducted in: Brazil
Unit of randomisation: not applicable
Unit of analysis: individual
Setting: children living in a Santo Antonio orphanage in the city of Niteroi, located 14 km from the city of Rio de Janeiro, Brazil
Funded by: "This study was financed by CAPES, Brazil. Partial support for the study was provided by Unigranrio (Duque de Caxias, Rio de Janeiro)"
Duration of the study: 6 months
Participants Inclusion criteria: children with all first molars erupted, children living at the orphanage
Exclusion criteria: not stated
Age at baseline: 7 to 11 years
N (controls baseline): 14
N (controls follow‐up): 12
N (interventions baseline): 28
N (interventions follow‐up): 25
Recruitment: from an orphanage
Gender: 100% female
Interventions Intervention: professional teeth cleaning, oral hygiene instructions and prophylaxis programme. Children received education on the origin and prevention of gingivitis, instructions on how to brush their teeth, demonstrations on oral hygiene practice and individual instructions
Control: not reported
Duration of intervention: 6 months
Outcomes Plaque index and gingival index
Implementation related factors Theoretical basis: social determinants of health, socio‐ecological model and health promotion
Resources for implementation: oral hygiene instruction, prophylaxis, rubber cups and abrasive paste, dental floss and toothbrushes, education and disclosing solution
Who delivered the intervention: nuns at the orphanage
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) High risk 42 children with all first molars erupted were selected from 80. They were stratified by age and were divided into 2 groups: 14 children serving as controls, and 28 as an experimental group
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 Unclear risk Unclear
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Unclear