Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
MaXED
1 other identifier
interventional
1,064
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 23, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 15, 2011
December 1, 2009
2.2 years
December 23, 2009
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Caries occurrence at the age 3 and 5 yrs;
5 years
Oral microbial colonization at 2 yrs
2 years
Secondary Outcomes (1)
To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)
2 years
Study Arms (2)
Childsmile programme with xylitol
ACTIVE COMPARATORChildsmile program with maternal xylitol consumption;
Childsmile programme only
PLACEBO COMPARATORChildsmile programme
Interventions
Mothers will eat 6 grams of xylitol per day
Mothers will receive the childsmile preventative programme
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Fifelead
- University of Turkucollaborator
Study Sites (1)
Brett Duane, NHS Fife
Leven, Fife, KY8 5RR, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
December 23, 2009
First Posted
December 24, 2009
Study Start
December 1, 2009
Primary Completion
March 1, 2012
Study Completion
May 1, 2016
Last Updated
June 15, 2011
Record last verified: 2009-12