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

NHS Fife

Status: Unknown

Conditions: Dental Caries; Oral Microbial Colonization

Treatments: Behavioral: Childsmile preventative programme; Dietary Supplement: Xylitol consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT01038479

09/S0501/49

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,064 estimated patients

Sex: All

Ages: 2 weeks to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,064 participants in 2 patient groups, including a placebo group

Childsmile programme with xylitol

Active Comparator group

Description:

Childsmile program with maternal xylitol consumption;

Treatment:

Dietary Supplement: Xylitol consumption

Behavioral: Childsmile preventative programme

Childsmile programme only

Placebo Comparator group

Description:

Childsmile programme

Treatment:

Behavioral: Childsmile preventative programme