Dental Caries Clinical Trial
Official title:
Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
The purpose of this study is to determine if the Childsmile programme (www.childāsmile.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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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