search
Back to results

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

Primary Purpose

Dental Caries, Oral Microbial Colonization

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Xylitol consumption
Childsmile preventative programme
Sponsored by
NHS Fife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Xylitol, Mutans streptococci, Maternal consumption, Early childhood tooth decay, Early childhood caries, Childsmile

Eligibility Criteria

2 Weeks - 5 Years (Child)All SexesAccepts 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

Sites / Locations

  • Brett Duane, NHS Fife

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Childsmile programme with xylitol

Childsmile programme only

Arm Description

Childsmile program with maternal xylitol consumption;

Childsmile programme

Outcomes

Primary Outcome Measures

Caries occurrence at the age 3 and 5 yrs;
Oral microbial colonization at 2 yrs

Secondary Outcome Measures

To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)

Full Information

First Posted
December 23, 2009
Last Updated
June 14, 2011
Sponsor
NHS Fife
Collaborators
University of Turku
search

1. Study Identification

Unique Protocol Identification Number
NCT01038479
Brief Title
Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Acronym
MaXED
Official Title
Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
NHS Fife
Collaborators
University of Turku

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Oral Microbial Colonization
Keywords
Xylitol, Mutans streptococci, Maternal consumption, Early childhood tooth decay, Early childhood caries, Childsmile

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1064 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Childsmile programme with xylitol
Arm Type
Active Comparator
Arm Description
Childsmile program with maternal xylitol consumption;
Arm Title
Childsmile programme only
Arm Type
Placebo Comparator
Arm Description
Childsmile programme
Intervention Type
Dietary Supplement
Intervention Name(s)
Xylitol consumption
Intervention Description
Mothers will eat 6 grams of xylitol per day
Intervention Type
Behavioral
Intervention Name(s)
Childsmile preventative programme
Other Intervention Name(s)
Mothers will receive the childsmile preventative programme
Intervention Description
Mothers will receive the childsmile preventative programme
Primary Outcome Measure Information:
Title
Caries occurrence at the age 3 and 5 yrs;
Time Frame
5 years
Title
Oral microbial colonization at 2 yrs
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Duane, BDS,MAM
Organizational Affiliation
NHS Fife
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Richards, BDS MPH
Organizational Affiliation
NHS Forth Valley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Soderling, PHD
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaisu Pienihäkkinen, DDS, PhD
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brett Duane, NHS Fife
City
Leven
State/Province
Fife
ZIP/Postal Code
KY8 5RR
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.nhsfife.scot.nhs.uk/CDS/approved%20full%20protocol%20V%206%5b1%5d.pdf
Description
Link to full protocol of study

Learn more about this trial

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

We'll reach out to this number within 24 hrs