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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Turku
Information provided by:
NHS Fife
ClinicalTrials.gov Identifier:
NCT01038479
First received: December 23, 2009
Last updated: June 14, 2011
Last verified: December 2009
  Purpose

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


Condition Intervention
Dental Caries
Oral Microbial Colonization
Dietary Supplement: Xylitol consumption
Behavioral: Childsmile preventative programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)

Resource links provided by NLM:


Further study details as provided by NHS Fife:

Primary Outcome Measures:
  • Caries occurrence at the age 3 and 5 yrs; [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Oral microbial colonization at 2 yrs [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1064
Study Start Date: December 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Childsmile programme with xylitol
Childsmile program with maternal xylitol consumption;
Dietary Supplement: Xylitol consumption
Mothers will eat 6 grams of xylitol per day
Behavioral: Childsmile preventative programme
Mothers will receive the childsmile preventative programme
Other Name: Mothers will receive the childsmile preventative programme
Placebo Comparator: Childsmile programme only
Childsmile programme
Behavioral: Childsmile preventative programme
Mothers will receive the childsmile preventative programme
Other Name: Mothers will receive the childsmile preventative programme

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038479

Locations
United Kingdom
Brett Duane, NHS Fife
Leven, Fife, United Kingdom, KY8 5RR
Sponsors and Collaborators
NHS Fife
University of Turku
Investigators
Principal Investigator: Brett Duane, BDS,MAM NHS Fife
Principal Investigator: Derek Richards, BDS MPH NHS Forth Valley
Principal Investigator: Eva Soderling, PHD University of Turku
Principal Investigator: Kaisu Pienihäkkinen, DDS, PhD University of Turku
  More Information

No publications provided

Responsible Party: Mr Brett Duane, NHS Fife
ClinicalTrials.gov Identifier: NCT01038479     History of Changes
Other Study ID Numbers: 09/S0501/49
Study First Received: December 23, 2009
Last Updated: June 14, 2011
Health Authority: United Kingdom: Tayside Committee on Medical Research Ethics
United States: Federal Government

Keywords provided by NHS Fife:
Xylitol
Mutans streptococci
Maternal consumption
Early childhood tooth decay
Early childhood caries
Childsmile

Additional relevant MeSH terms:
Dental Caries
Infection
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 24, 2014