Dental CariesMaXEDNCT01038479
Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
A study testing Xylitol consumption and Childsmile preventative programme in people with Dental Caries and Oral Microbial Colonization, run by NHS Fife at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Oral Microbial Colonization
- What is being tested?
- Xylitol consumption and Childsmile preventative programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,064 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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.
- Conditions
- Dental Caries, Oral Microbial Colonization
- Being tested
- Xylitol consumption, Childsmile preventative programme
- Keywords
- Xylitol, Mutans streptococci, Maternal consumption, Early childhood tooth decay, Early childhood caries, Childsmile
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol consumptionDietary supplement
Mothers will eat 6 grams of xylitol per day
Childsmile preventative programmeBehavioural
Also called Mothers will receive the childsmile preventative programme
Mothers will receive the childsmile preventative programme
| Study group | Role | What they receive |
|---|---|---|
| Childsmile programme with xylitol | Active comparator | Childsmile program with maternal xylitol consumption; Receives: Dietary Supplement: Xylitol consumption; Behavioral: Childsmile preventative programme |
| Childsmile programme only | Placebo comparator | Childsmile programme Receives: Behavioral: Childsmile preventative programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries occurrence at the age 3 and 5 yrs;
Measured: 5 years
Oral microbial colonization at 2 yrs
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2012 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,064 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Fife
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Investigators
- Brett Duane, BDS,MAM, Principal investigator, NHS FifeDerek Richards, BDS MPH, Principal investigator, NHS Forth ValleyEva Soderling, PHD, Principal investigator, University of TurkuKaisu Pienihäkkinen, DDS, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038479
- Sponsor's protocol ID
- 09/S0501/49
- Acronym
- MaXED
- Status last verified
- Dec 2009
- First submitted
- 23 Dec 2009
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
- ClinicalTrials.gov ID
- NCT01038479
- Acronym / sponsor ID
- MaXED / 09/S0501/49
- Conditions
- Dental Caries, Oral Microbial Colonization
- Keywords
- Xylitol, Mutans streptococci, Maternal consumption, Early childhood tooth decay, Early childhood caries, Childsmile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,064 participants (estimated)
- Lead sponsor
- NHS FifeOther government
- Collaborators
- University of Turku
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Childsmile programme with xylitol | Active comparator | Dietary Supplement: Xylitol consumption, Behavioral: Childsmile preventative programmeChildsmile program with maternal xylitol consumption; |
| Childsmile programme only | Placebo comparator | Behavioral: Childsmile preventative programmeChildsmile programme |
Who may qualify
- Ages
- 2 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol consumptionMothers will eat 6 grams of xylitol per day | Dietary supplement | Childsmile programme with xylitol |
| Childsmile preventative programmeAlso: Mothers will receive the childsmile preventative programmeMothers will receive the childsmile preventative programme | Behavioural | Childsmile programme only, Childsmile programme with xylitol |
Primary outcome
Caries occurrence at the age 3 and 5 yrs;
Time frame: 5 years
Oral microbial colonization at 2 yrs
Time frame: 2 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
- Link to full protocol of studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Duane, BDS,MAM principal investigator
NHS Fife
Derek Richards, BDS MPH principal investigator
NHS Forth Valley
Eva Soderling, PHD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol consumption and Childsmile preventative programme in people with Dental Caries and Oral Microbial Colonization, run by NHS Fife at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries occurrence at the age 3 and 5 yrs; (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2011.