NCT01038479.

Trial name or title	Maternal consumption of xylitol to reduce early childhood decay (MaXED Study) (MaXED)
Methods	RCT: NCT01038479
Participants	Recruitment target: 1064 participants Inclusion criteria: mother with high counts of mutans streptococci (equal or higher than log 5); child less than 3 months of age; mother who has a close relationship with Fife (e.g. lives or works in Fife); child seen by health visitor; mother is the main carer of her child(ren) Exclusion criteria: mother with low or no mutans streptococci; child older than 3 months of age; child not seen by health visitor; no close relationship with Fife (e.g. doesn't live or work in Fife); mother is not the main carer of child(ren) Setting: UK (Scottish population)
Interventions	Intervention group: maternal consumption of 5 grams of xylitol per day plus Childsmile preventative programme (www.child‐smile.org) Control group: Childsmile preventative programme
Outcomes	Primary outcome: caries occurrence in children, assessed at age 3 and 5 years; oral microbial colonisation in children, assessed at 2 years Other outcomes: mother acceptability of the invention, qualitative assessment using periodic questionnaires, assessed at 2 years
Starting date	December 2009
Contact information	Brett Duane, email: not reported
Notes	Address of principal investigator: Leven, Fife, United Kingdom, KY8 5RR