Plutzer 2012
Methods |
Study design: randomised controlled trial Conducted in: Adelaide, Australia Unit of randomisation: mother‐baby pair Unit of analysis: individual Setting: public maternity hospitals Funded by: "The study was supported by the NHMRC Centre of Clinical Research Excellence, Adelaide, South Australia" Duration of the study: 7 years |
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Participants |
Inclusion criteria: not reported Exclusion criteria: pregnant women at high risk and with multiple pregnancies, incomplete questionnaires and inability to comprehend written English Age at baseline: 18 months N (controls baseline): 322 N (controls follow‐up): 136 N (interventions baseline): 327 N (interventions follow‐up): 141 Recruitment: Nulliparous women were recruited into the study in their 5th to 7th month of pregnancy during regular antenatal visits at participating health facilities Gender: not reported |
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Interventions |
Intervention
Control: no intervention Duration of intervention: 1 year |
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Outcomes | Dental caries (dmft, dmfs) | |
Implementation related factors |
Theoretical basis: not reported Resources for implementation: not reported Who delivered the intervention: unclear PROGRESS categories assessed at baseline: education, SES PROGRESS categories analysed at outcome: education, SES Outcomes related to harms/unintended effects: not reported Intervention included strategies to address diversity or disadvantage: not reported Economic evaluation: not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number tables were used to generate allocation sequence |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Retention rates were similar in both intervention and control groups and were influenced by the same determinants. Attrition bias occurred to the same extent and for the same reasons in both arms of the trial |
Selective reporting (reporting bias) | Low risk | Published report presents all expected outcomes of interest to the review |
Other bias | High risk | Study authors acknowledge that contamination occurred during examination at 20 months |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Examiners were unaware of the group to which the child belonged |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear |