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

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ClinicalTrials.gov Identifier: NCT01038479
Recruitment Status : Unknown
Verified December 2009 by NHS Fife.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2009
Last Update Posted : June 15, 2011
Sponsor:
Collaborator:
University of Turku
Information provided by:
NHS Fife

Tracking Information
First Submitted Date  ICMJE December 23, 2009
First Posted Date  ICMJE December 24, 2009
Last Update Posted Date June 15, 2011
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
  • Caries occurrence at the age 3 and 5 yrs; [ Time Frame: 5 years ]
  • Oral microbial colonization at 2 yrs [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01038479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
Official Title  ICMJE Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Dental Caries
  • Oral Microbial Colonization
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Childsmile programme with xylitol
    Childsmile program with maternal xylitol consumption;
    Interventions:
    • Dietary Supplement: Xylitol consumption
    • Behavioral: Childsmile preventative programme
  • Placebo Comparator: Childsmile programme only
    Childsmile programme
    Intervention: Behavioral: Childsmile preventative programme
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 23, 2009)
1064
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01038479
Other Study ID Numbers  ICMJE 09/S0501/49
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr Brett Duane, NHS Fife
Study Sponsor  ICMJE NHS Fife
Collaborators  ICMJE University of Turku
Investigators  ICMJE
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
PRS Account NHS Fife
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP