Study on Use of Xylitol-wipes to Prevent Dental Caries (WIPE)
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
xylitol wipe
placebo wipe
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring dental caries, mutans streptococci, lactobacilli, bacterial transmission, bacterial colonization
Eligibility Criteria
Inclusion Criteria:
- mothers presenting with active dental decay or restorations within the past year (high caries risk)
- mothers who are the primary caregivers for their child
- healthy children without systemic disease aged 6 months to two years
- Infants younger than 6 months who have one or more teeth present
Exclusion Criteria:
- mother or child with systemic disease
- antibiotics or medications taken within the previous 3 months that may alter oral flora and saliva flow for mother or child
- children who primarily receive care in a daycare center or by a caregiver other than the mother
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
xylitol wipe
placebo wipe
Arm Description
Outcomes
Primary Outcome Measures
new decayed surfaces
Secondary Outcome Measures
salivary levels of Mutans Streptococci
levels of lactobacilli
Full Information
NCT ID
NCT01468727
First Posted
November 7, 2011
Last Updated
November 14, 2011
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01468727
Brief Title
Study on Use of Xylitol-wipes to Prevent Dental Caries
Acronym
WIPE
Official Title
Effectiveness of Xylitol Wipes on Infants in Reducing Bacterial Transmission and Colonization From Mother to Child
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mutans streptococci (MS) and lactobacillus species (LB) are the two groups of infectious cariogenic (caries-causing) bacteria most strongly associated with dental caries (dental decay). Infants acquire cariogenic bacteria from their mothers early in development via saliva. There have been several studies that have demonstrated a significant reduction in dental caries associated with consumption of the food additive known as xylitol in children and adults. Xylitol is a non-toxic 5 carbon polyol, approved as a food additive by the FDA, that tastes like and behaves like sucrose in humans. Xylitol is used as a sugar substitute to reduce dental caries as it is not fermentable by the caries causing bacteria. In addition, an observed positive beneficial side effect of this sugar substitute is that xylitol has been shown to reduce mother to child bacterial transfer when used by the mother. It is commonly recommended to wipe infants' teeth and gums with a soft cloth to reduce the formation of dental bacterial plaque. Recently wipes have been marketed that contain xylitol to provide a safe sweet sensation for the infant during this cleaning procedure. However, no study has been conducted that assesses the biological effect of applying xylitol directly to the teeth and gums of infants. This study will be conducted to test whether xylitol applied by swab directly to the infant's teeth and gums will effectively reduce bacterial transfer from mother to child. Children age up to two years old whose mothers have high cariogenic bacterial counts will be recruited to use xylitol wipes 3-4 times daily in addition to their normal preventive regimen. This will be a randomized double blinded study where the control group will receive placebo wipes (with no xylitol) and the experimental group will receive the xylitol wipes. The mother-child pair MS and LB bacterial counts and caries score of the children will be measured at baseline, 3 months, 6 months and 1 year. We will contact all patients that were recruited into the study to inquire whether they are willing to return for further follow-up visits at 1, 2, 3, and 4 years post-wipe treatment completion. If successful, this study will support the use of a simple caries preventive measure that could be easily and safely implemented in young children. Ten MS isolates and unique LB colonies will be isolated from each saliva samples to study their genetic diversities and virulence factors.
The investigators will also investigate whether specific MS genes relate to ECC prevention effect of daily xylitol-wipe application using genomic sequencing of MS isolated from current study when the active intervention was applied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, mutans streptococci, lactobacilli, bacterial transmission, bacterial colonization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
xylitol wipe
Arm Type
Experimental
Arm Title
placebo wipe
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
xylitol wipe
Intervention Description
Parents were instructed to wipe their infants' teeth and gums three times per day with two wipes each time after feeding in addition to their daily tooth brushing.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo wipe
Intervention Description
Parents were instructed to wipe their infants' teeth and gums three times per day with two wipes each time after feeding in addition to their daily tooth brushing.
Primary Outcome Measure Information:
Title
new decayed surfaces
Time Frame
1 year
Secondary Outcome Measure Information:
Title
salivary levels of Mutans Streptococci
Time Frame
3 month, 6 month, 1 year
Title
levels of lactobacilli
Time Frame
3 month, 6 month, and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
mothers presenting with active dental decay or restorations within the past year (high caries risk)
mothers who are the primary caregivers for their child
healthy children without systemic disease aged 6 months to two years
Infants younger than 6 months who have one or more teeth present
Exclusion Criteria:
mother or child with systemic disease
antibiotics or medications taken within the previous 3 months that may alter oral flora and saliva flow for mother or child
children who primarily receive care in a daycare center or by a caregiver other than the mother
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22699675
Citation
Zhan L, Cheng J, Chang P, Ngo M, Denbesten PK, Hoover CI, Featherstone JD. Effects of xylitol wipes on cariogenic bacteria and caries in young children. J Dent Res. 2012 Jul;91(7 Suppl):85S-90S. doi: 10.1177/0022034511434354.
Results Reference
derived
Learn more about this trial
Study on Use of Xylitol-wipes to Prevent Dental Caries
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