Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- NHS Fife
- Enrollment
- 1,064
- Locations
- 1
- Primary Endpoint
- Caries occurrence at the age 3 and 5 yrs;
Study Overview
Brief Summary
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
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 2 Weeks to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Childsmile programme only
Childsmile programme
Intervention: Childsmile preventative programme (Behavioral)
Childsmile programme with xylitol
Childsmile program with maternal xylitol consumption;
Intervention: Xylitol consumption (Dietary Supplement)
Childsmile programme with xylitol
Childsmile program with maternal xylitol consumption;
Intervention: Childsmile preventative programme (Behavioral)
Outcomes
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)(2 years)