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

NCT01038479 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1064

Last updated 2011-06-15

No results posted yet for this study

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

Conditions

  • Dental Caries
  • Oral Microbial Colonization

Interventions

DIETARY_SUPPLEMENT

Xylitol consumption

Mothers will eat 6 grams of xylitol per day

BEHAVIORAL

Childsmile preventative programme

Mothers will receive the childsmile preventative programme

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER

  • NHS Fife

    lead OTHER_GOV

Principal Investigators

  • Brett Duane, BDS,MAM · NHS Fife

  • Derek Richards, BDS MPH · NHS Forth Valley

  • Eva Soderling, PHD · University of Turku

  • Kaisu Pienihäkkinen, DDS, PhD · University of Turku

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-03-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038479 on ClinicalTrials.gov