Thorild 2003.
Methods | Randomised controlled trial (multi‐arm trial, with 3 arms) | |
Participants | 173 women (new mothers) and their infants were randomised (116 to the groups included in this review). Inclusion criteria: healthy mothers with high counts of salivary mutans streptococci (MS) (> 150 CFU) and their three‐month old infants residing in the study area Exclusion criteria: not reported Setting: city of Varberg, a mid‐sized community in south‐west Sweden Important health characteristics of mothers reported: included women had high counts of salivary mutans streptococci at 3 months postpartum, otherwise healthy. |
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Interventions |
Group 1: xylitol gum (n = 61 randomised) Women received gum containing 650 mg xylitol (Xylitol, Leaf, Finland), total weight/gum 1050 mg; requested to chew three pieces/day, for five minutes, in the morning, at noon, and in the evening. Group 2: chlorhexidine/xylitol gum (n = 55 randomised) Women received gum containing 532.5 mg xylitol, 5.0 mg chlorhexidine, and 141.9 mg sodium fluoride for a total weight/gum 1120.1 mg; they were requested to chew three pieces daily for five minutes, in the morning, at noon and in the evening. Group 3: sodium fluoride/xylitol gum (n = 57 randomised) Women received gum containing 288.5 mg xylitol, 188.8 mg sorbitol and 0.55 mg sodium fluoride, total weight/gum 870 mg; they were requested to chew 3 pieces daily, for five minutes, in the morning, at noon and in the evening. Intervention timing: intervention delivered 6 though 18 months postpartum (> 6 months intervention duration) Theory or model used as a basis for intervention: not reported |
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Outcomes |
Data in meta‐analysis for: primary outcome: caries presence in primary teeth; defs score; defs score categories; secondary outcomes: child microbiological presence: mutans streptococci colonisation (any); child microbiological presence; mutans streptococci score categories Additional narrative text for: none Tabulated data for: none Additional outcomes that had not been prespecified: Child: none reported. Mother: none reported |
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Notes |
Funding: "The study was supported by grants from the Swedish Dental Society, the Swedish Patent Revenue Fund and the County Councils of Halland and Västerbotten". Declarations of interest: none declared As fluoride is not an eligible intervention in this review, we have excluded the sodium fluoride/xylitol/sorbitol gum group, and included this trial in the comparison of xylitol versus CHX combined with xylitol. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Three experimental groups and one reference group were formed on the basis of the maternal MS counts. The mothers with high counts of salivary MS (≥ 150 colony forming units CFU) were randomly assigned to three experimental groups". |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported; unlikely considering the type of intervention assessed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all children were examined in a dental chair by one trained examiner (IT) blind to which group the child belonged". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | At the 3‐year time point: 56/61 (91%) and 44/55 (80%) of infants were available for assessment in the xylitol and CHX/ and fluoride groups respectively. At the 4‐year data collection time point: 52/61 (85%) and 44/55 (80%) infants of mothers randomised to the xylitol and CHX/xylitol groups, respectively, were available for assessment. |
Selective reporting (reporting bias) | Unclear risk | Without access to study protocol, cannot assess confidently as high or low risk |
Other bias | Low risk | There were no signs of other bias in the study reporting. |