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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01468727

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Dietary Supplement: xylitol wipe Dietary Supplement: placebo wipe	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

new decayed surfaces [1 year]

Secondary Outcome Measures

salivary levels of Mutans Streptococci [3 month, 6 month, 1 year]
levels of lactobacilli [3 month, 6 month, and one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 35 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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