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

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
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
Interventions Intervention
  • Oral health education through 3 rounds of printed information. This included oral health education on oral health changes during pregnancy, use of pacifiers, oral hygiene during tooth eruption and feeding practices


Control: no intervention
Duration of intervention: 1 year
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
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