Hallas 2015.

Methods	RCT
Participants	94 women (new mothers) and their infants were randomised. Inclusion criteria: all mothers who delivered a healthy full‐term infant at Bellevue Hospital were eligible to participate in the study while they were on the postpartum unit and to participate in the 6‐month and 12‐month follow‐up program for evaluation of the infant’s oral health status. Exclusion criteria: not reported Setting: Bellevue Hospital, a major urban academic teaching hospital in Manhattan, New York, USA (study conducted from 4 January 2010 to 4 January 2011) Important health characteristics reported: Cree children in the included communities known to be at a higher risk of dental disease, including early childhood caries (ECC), than nonIndigenous children in Canada
Interventions	Group 1 (n = 47 women randomised) Mothers viewed an 8‐minute newborn oral health educational digital versatile disc (DVD) at the bedside, designed by the principal investigator and co‐investigators based on the best available evidence for oral healthcare for infants and young children to prevent formation of white spots, demineralisation, and dental caries in the first few years of life. The content of the video included: goals for growing up cavity free; definition of early childhood caries; pattern of tooth eruption; how to keep baby teeth healthy; newborn and infant oral care by parents; when to start brushing baby teeth; when to use toothpaste with fluoride; sleep time habits; teething: dispelling myths; teething symptoms; bacterial transmission from mother to baby; importance of mother caring for her own teeth; infant diet: avoiding sugary foods; diet and health; bad eating habits; establishing the dental home; the first dental home; fluoride varnish Group 2 (n = 37 women randomised) Mothers randomised to the control group viewed a standardised 8‐minute DVD on nutrition for newborns and infants. Intervention timing: delivered in the immediate postpartum period, during mothers' postnatal hospital stay (intervention duration < 6 months) Theory or model used as a basis for intervention: authors stated that the intervention was informed by evidence on best practice for infant oral health. All participants: mothers in both groups received routine newborn education by nurses, the lactation consultant, physicians, and residents. This included information on feeding and bathing the infant and identification of signs of illness but did not include any oral health education or instruction.
Outcomes	Data in meta‐analysis for: primary outcome: none; secondary outcomes: none Narrative text for: any caries presence in primary teeth Tabulated data for: none Additional outcomes that had not been prespecified: Child: none reported. Mother: none reported
Notes	Funding: grant from the American Dental Association and the Samuel D. Harris Fund for Children’s Dental Health Declarations of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "A computer was used to randomly assign 47 mothers to the treatment group and 47 mothers to the control group".
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and personnel not reported and unlikely that participants or personnel were blind to group assignment considering the type of intervention assessed.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Authors stated that "assessments were conducted at 2 clinics by non‐study staff"; no other details provided.
Incomplete outcome data (attrition bias) All outcomes	High risk	Due to significant no show, child caries were not reported by group, nor was the second study outcome for inclusion in this review, mothers self‐reported oral health behaviour reported by group. Quote: "Despite numerous efforts to contact each mother who enrolled in the study to remind her to return with her infant for the 6‐month and 12‐month oral health assessment follow‐up visits at either the Bellevue or NYU paediatric dental clinic, only 10 mothers returned for both the 6‐month and 12‐month infant follow‐up visits. Therefore, data analysis for statistical significance for follow‐up visits could not be conducted as planned”.
Selective reporting (reporting bias)	Unclear risk	Without access to the study protocol, it was not possible to confidently assess this trial as being at high risk or low risk of selective reporting.
Other bias	Unclear risk	Limited data comparing key characteristics of participants provided and therefore not clear how similar the groups were at baseline and caries assessment