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

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

Study Overview

• Status: Unknown
• Conditions: Dental Caries; Oral Microbial Colonization
• Intervention / Treatment: Dietary supplement: Xylitol consumption; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1064
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Fife
    • Leven, Fife, United Kingdom, KY8 5RR
      • Brett Duane, NHS Fife

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Mothers will receive the childsmile preventative programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Caries occurrence at the age 3 and 5 yrs;	5 years
Oral microbial colonization at 2 yrs	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)	2 years

Collaborators and Investigators

• Sponsor: NHS Fife
• Collaborators: 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

Publications and helpful links

Helpful Links

• Link to full protocol of study

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Xylitol; Mutans streptococci; Maternal consumption; Early childhood tooth decay; Early childhood caries; Childsmile
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Infections; Communicable Diseases; Dental Caries
• Other Study ID Numbers: 09/S0501/49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No