Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
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Purpose
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
| Condition | Intervention |
|---|---|
|
Dental Caries Oral Microbial Colonization |
Dietary Supplement: Xylitol consumption Behavioral: Childsmile preventative programme |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study) |
- Caries occurrence at the age 3 and 5 yrs; [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Oral microbial colonization at 2 yrs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1064 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Childsmile programme with xylitol
Childsmile program with maternal xylitol consumption;
|
Dietary Supplement: Xylitol consumption
Mothers will eat 6 grams of xylitol per day
Behavioral: Childsmile preventative programme
Mothers will receive the childsmile preventative programme
Other Name: Mothers will receive the childsmile preventative programme
|
|
Placebo Comparator: Childsmile programme only
Childsmile programme
|
Behavioral: Childsmile preventative programme
Mothers will receive the childsmile preventative programme
Other Name: Mothers will receive the childsmile preventative programme
|
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.
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.
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United Kingdom | |
| Brett Duane, NHS Fife | |
| Leven, Fife, United Kingdom, KY8 5RR | |
| Principal Investigator: | Brett Duane, BDS,MAM | NHS Fife |
| Principal Investigator: | Derek Richards, BDS MPH | NHS Forth Valley |
| Principal Investigator: | Eva Soderling, PHD | University of Turku |
| Principal Investigator: | Kaisu Pienihäkkinen, DDS, PhD | University of Turku |
More Information
No publications provided
| Responsible Party: | Mr Brett Duane, NHS Fife |
| ClinicalTrials.gov Identifier: | NCT01038479 History of Changes |
| Other Study ID Numbers: | 09/S0501/49 |
| Study First Received: | December 23, 2009 |
| Last Updated: | June 14, 2011 |
| Health Authority: | United Kingdom: Tayside Committee on Medical Research Ethics United States: Federal Government |
Keywords provided by NHS Fife:
|
Xylitol Mutans streptococci Maternal consumption |
Early childhood tooth decay Early childhood caries Childsmile |
Additional relevant MeSH terms:
|
Dental Caries Infection Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013