Study on Use of Xylitol-wipes to Prevent Dental Caries (WIPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01468727
First received: November 7, 2011
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Dental Caries
Dietary Supplement: xylitol wipe
Dietary Supplement: placebo wipe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Xylitol Wipes on Infants in Reducing Bacterial Transmission and Colonization From Mother to Child

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • new decayed surfaces [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • salivary levels of Mutans Streptococci [ Time Frame: 3 month, 6 month, 1 year ] [ Designated as safety issue: No ]
  • levels of lactobacilli [ Time Frame: 3 month, 6 month, and one year ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: xylitol wipe Dietary Supplement: xylitol wipe
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.
Placebo Comparator: placebo wipe Dietary Supplement: placebo wipe
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.

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. mothers presenting with active dental decay or restorations within the past year (high caries risk)
  2. mothers who are the primary caregivers for their child
  3. healthy children without systemic disease aged 6 months to two years
  4. Infants younger than 6 months who have one or more teeth present

Exclusion Criteria:

  1. mother or child with systemic disease
  2. antibiotics or medications taken within the previous 3 months that may alter oral flora and saliva flow for mother or child
  3. children who primarily receive care in a daycare center or by a caregiver other than the mother
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468727

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01468727     History of Changes
Other Study ID Numbers: A110449
Study First Received: November 7, 2011
Last Updated: November 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
dental caries
mutans streptococci
lactobacilli
bacterial transmission
bacterial colonization

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on October 30, 2014