This trial is active, not recruiting.

Conditions dental caries, oral microbial colonization
Treatments xylitol consumption, childsmile preventative programme
Sponsor NHS Fife
Collaborator University of Turku
Start date December 2009
End date March 2012
Trial size 1064 participants
Trial identifier NCT01038479, 09/S0501/49


The purpose of this study is to determine if the Childsmile programme (www.child−smile.org) with the additional maternal use of xylitol is more effective at reducing dental decay in children than a Childsmile program alone.

The children will be compared in the two groups at age two, to determine how the interventions affected the early colonization of mutans streptococci, an important risk factor of tooth decay.

At three and at five years the investigators will also examine the amount of tooth decay in these children.

Using MIDAS (Scotland's national health service dental data) records, the investigators will follow the oral health of the children until the age of 5 years.

Main hypothesis:

The maternal consumption of xylitol reduces early childhood caries

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
(Active Comparator)
Childsmile program with maternal xylitol consumption;
xylitol consumption
Mothers will eat 6 grams of xylitol per day
childsmile preventative programme Mothers will receive the childsmile preventative programme
Mothers will receive the childsmile preventative programme
(Placebo Comparator)
Childsmile programme
childsmile preventative programme Mothers will receive the childsmile preventative programme
Mothers will receive the childsmile preventative programme

Primary Outcomes

Caries occurrence at the age 3 and 5 yrs;
time frame: 5 years
Oral microbial colonization at 2 yrs
time frame: 2 years

Secondary Outcomes

To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)
time frame: 2 years

Eligibility Criteria

Male or female participants up to 5 years old.

Inclusion Criteria: - Mother with high counts of MS (MS equal or higher than log 5) - Child less than 3 months of age - Has a close relationship with Fife (e.g. lives or works in Fife) - Child seen by health visitor - Mother who is the main carer of her children Exclusion Criteria: - Mother with low or no MS - 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 who is not the main carer of her children

Additional Information

Official title Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Principal investigator Brett Duane, BDS,MAM
Description Xylitol has been shown to decrease mutans streptococci transmission between mother and child. Such maternal consumption of xylitol studies have, however not been tested in a Scottish population. Sign 83, (www.sign.ac.uk/pdf/sign83.pdf) a Scottish government publication states that carrying out research in this area is needed. Childsmile (www.child-smile.org) is a Scottish government programme that promotes oral health from birth, particularly amongst people living in priority areas. Parents of newborn children who are assessed to be at risk of developing tooth decay are referred to the programme by their Health Visitor. Parents are visited at home by a Dental Health Support Worker. The dental health support worker will give more information, advice and arrange regular visits for participants to their local Dental Practice. This research study will compare two groups; one group randomised into the childsmile preventative programme, the other group randomised into the childsmile preventative programme plus consuming 5 grams of xylitol per day. We will be testing the mutans streptococci of the mother, at start of the study, and testing the mutans streptococci of mother and child at (child) aged two, in both groups- We will then be testing the dental decay of children in both groups The research study will use existing NHS fife funding. NHS Fife currently employs approximately 15 dental health support workers, of which part of their role will be to support this project Recruiting of study is planned to start in January 2010.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by NHS Fife.