Clinical Trial: Study on Use of Xylitol-wipes to Prevent Dental Caries
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effectiveness of Xylitol Wipes on Infants in Reducing Bacterial Transmission and Colonization From Mother to Child
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,
Detailed Summary:
Sponsor: University of California, San Francisco
Current Primary Outcome: new decayed surfaces [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- salivary levels of Mutans Streptococci [ Time Frame: 3 month, 6 month, 1 year ]
- levels of lactobacilli [ Time Frame: 3 month, 6 month, and one year ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: November 7, 2011
Date Started: January 2007
Date Completion:
Last Updated: November 14, 2011
Last Verified: November 2011
