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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1064 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-05-31

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

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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.

Conditions

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Dental Caries Oral Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Childsmile programme with xylitol

Childsmile program with maternal xylitol consumption;

Group Type ACTIVE_COMPARATOR

Xylitol consumption

Intervention Type DIETARY_SUPPLEMENT

Mothers will eat 6 grams of xylitol per day

Childsmile preventative programme

Intervention Type BEHAVIORAL

Mothers will receive the childsmile preventative programme

Childsmile programme only

Childsmile programme

Group Type PLACEBO_COMPARATOR

Childsmile preventative programme

Intervention Type BEHAVIORAL

Mothers will receive the childsmile preventative programme

Interventions

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Xylitol consumption

Mothers will eat 6 grams of xylitol per day

Intervention Type DIETARY_SUPPLEMENT

Childsmile preventative programme

Mothers will receive the childsmile preventative programme

Intervention Type BEHAVIORAL

Other Intervention Names

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Mothers will receive the childsmile preventative programme

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

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes