Study on Use of Xylitol-wipes to Prevent Dental Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

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.
    


Intervention name(s): xylitol wipe; placebo wipe
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dental caries; mutans streptococci; lactobacilli; bacterial transmission; bacterial colonization