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

Dental Caries Clinical Trial

— MaXED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01038479
• Other study ID #: 09/S0501/49
• Status: Active, not recruiting
• Phase: N/A
• First received: December 23, 2009
• Last updated: June 14, 2011
• Start date: December 2009
• Est. completion date: May 2016

Study information

• Verified date: December 2009
• Source: NHS Fife
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Tayside Committee on Medical Research EthicsUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1064
• Est. completion date: May 2016
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Caries
• Infection
• Oral Microbial Colonization

Intervention

Dietary Supplement:
• Xylitol consumption
Mothers will eat 6 grams of xylitol per day

Behavioral:
• Childsmile preventative programme
Mothers will receive the childsmile preventative programme

Locations

Country	Name	City	State
United Kingdom	Brett Duane, NHS Fife	Leven	Fife

Sponsors (2)

Lead Sponsor	Collaborator
NHS Fife	University of Turku

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries occurrence at the age 3 and 5 yrs;		5 years	No
Primary	Oral microbial colonization at 2 yrs		2 years	No
Secondary	To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)		2 years	No

External Links

•   Link to full protocol of study