Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)

Conditions
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Dental Caries, Oral Microbial Colonization

Intervention / Treatment
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* Dietary Supplement: Xylitol consumption
* Behavioral: Childsmile preventative programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Childsmile programme with xylitol<br>Childsmile program with maternal xylitol consumption; | Dietary Supplement: Xylitol consumption<br>* Mothers will eat 6 grams of xylitol per day<br>Behavioral: Childsmile preventative programme<br>* Mothers will receive the childsmile preventative programme<br>* Other names: Mothers will receive the childsmile preventative programme;|
| Placebo Comparator: Childsmile programme only<br>Childsmile programme | Behavioral: Childsmile preventative programme<br>* Mothers will receive the childsmile preventative programme<br>* Other names: Mothers will receive the childsmile preventative programme;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries occurrence at the age 3 and 5 yrs; |  | 5 years | 
| Oral microbial colonization at 2 yrs |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xylitol, Mutans streptococci, Maternal consumption, Early childhood tooth decay, Early childhood caries, Childsmile