Clinical trial NCT01038479: Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Official title: Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Oral Microbial Colonization
Keywords: Xylitol
Mutans streptococci
Maternal consumption
Early childhood tooth decay
Early childhood caries
Childsmile
Lead sponsor: NHS Fife
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2009-12-24
Enrollment: 1064
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: 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

Primary outcomes:
measure: Caries occurrence at the age 3 and 5 yrs;
timeFrame: 5 years
measure: Oral microbial colonization at 2 yrs
timeFrame: 2 years
Secondary outcomes:
measure: To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)
timeFrame: 2 years
Other outcomes:
Locations:
city: Leven
country: United Kingdom
facility: Brett Duane, NHS Fife
state: Fife
Study officials:
affiliation: NHS Fife
name: Brett Duane, BDS,MAM
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Forth Valley
name: Derek Richards, BDS MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Eva Soderling, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Kaisu Pienihäkkinen, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: