Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Not applicable Interventional Accepts healthy volunteers

Study on Use of Xylitol-wipes to Prevent Dental Caries

ClinicalTrials.gov ID: NCT01468727

Public ClinicalTrials.gov record NCT01468727. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 1:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Effectiveness of Xylitol Wipes on Infants in Reducing Bacterial Transmission and Colonization From Mother to Child

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01468727
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
88 participants

Conditions and interventions

Conditions

Interventions

Dietary Supplement

Eligibility (public fields only)

Age range
6 Months to 35 Months
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2006
Primary completion
Dec 31, 2007
Completion
Dec 31, 2007
Last update posted
Nov 15, 2011

2007 – 2008

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of California, San Francisco San Francisco California 94143

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01468727, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 15, 2011 · Synced Sep 5, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01468727 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →