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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: Completed NA study, sponsored by University of California, San Francisco.

NCT01468727 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 88 participants
Start Date 2007-01
Est. Completion 2008-01
Phase NA

What the finished NCT01468727 record still lists

NCT01468727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which xylitol wipe is the first listed.

NCT01468727 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01468727's enrollment target sits among peer trials

88 972nd of 2000 higher than 1,027 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01468727, the US trial registry maintained by the National Library of Medicine. NCT01468727 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.