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NCT01468727 · ClinicalTrials.gov registry record · NA
Study on Use of Xylitol-wipes to Prevent Dental Caries
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT01468727 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 88 participants.
The verdict
NCT01468727, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study 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 pati
Interventions
- DIETARY_SUPPLEMENT xylitol wipe
- DIETARY_SUPPLEMENT placebo wipe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01468727
The ClinicalTrials.gov registry entry for NCT01468727 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which xylitol wipe is the first listed.
NCT01468727 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01468727 about?
NCT01468727 is a clinical study titled "Study on Use of Xylitol-wipes to Prevent Dental Caries". 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 st...
What is the current status of trial NCT01468727?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2007-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT01468727?
The interventions under investigation include: xylitol wipe (DIETARY_SUPPLEMENT), placebo wipe (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01468727?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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