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Preventing Childhood Caries with Chlorhexidine Varnish

Final Report

Preventing Childhood Caries with Chlorhexidine Varnish Final Report (PDF)


  • Women/Maternal
  • Perinatal/Infancy (0-12 months)
  • Toddlerhood (13-35 months)

Targeted/Underserved Population

  • Native American/Alaskan Native


Dental caries (tooth decay) is the single most prevalent chronic disease among U.S. children, occurring 5 - 8 times as frequently as asthma, the second most common chronic disease in children. Early childhood caries (ECC) is a particularly virulent form of caries that affects infants, toddlers and preschool children. The disease burden of ECC goes beyond the pain and infection. Severe ECC often affects a child's ability to eat, speak, and communicate. In the U.S. the population group with one of the highest rates of ECC is American Indians and Alaska Natives (AI/AN). Nationwide, approximately 76 percent of AI/AN 2 - 4 year olds have decay, compared to 18% of non-AI/AN in the same age group. ECC results from an infectious disease, with the primary etiologic agent being mutans streptococci (MS). The major reservoir from which infants acquire MS is their mother or primary caregiver. If maternal levels of MS are low during the first two years of the child's life, the child is less likely to acquire MS and to develop ECC. The antimicrobial chlorhexidine (CHX) is effective in reducing oral MS levels. This study is a randomized, double blind, placebo-controlled clinical trial designed to test the efficacy of a 10% CHX varnish for the prevention of ECC in a very high risk population of AI/AN children. Mothers with children less than 5 months of age will be recruited at four tribal community sites. When the child is 5 - 6 months old, mothers will receive four weekly applications of a CHX or placebo varnish, followed by additional applications when the child is 12 months and 18 months of age. The mother-child pair will receive calibrated dental examinations when the child is 5, 12, 18, and 24 months of age. The primary outcome variable will be the number of decayed, missing, and filled primary tooth surfaces (dmfs) when the child is 24 months of age. Six hundred mother-child pairs will be enrolled during the course of the study. If successful, this study could pave the way for an effective new primary prevention modality for ECC using chlorhexidine varnish applied to mothers' teeth.

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