Center to Address Disparities in Childrens Oral Health

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Center to Address Disparities in Childrens Oral
Health

• Supported by the DHHS/NIH
• National Institute of Dental and Craniofacial
  Research
• National Center on Minority Health and Health
  Disparities
• U54 DE 14251

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FLUORIDE VARNISH RCT

• This randomized clinical trial (RCT) is testing
  the efficacy of different frequencies of fluoride
  varnish and parental counseling to prevent early
  childhood caries.

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Two diverse, low socio-economic status sites

• San Francisco General Hospital Family Dental
  Center

• Chinatown Public Health Center

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ELIGIBILITY CRITERIA

• Children lt 44 months old
• Caries-free
• 4 erupted maxillary incisors
• Residing in fluoridated community
• (San Francisco)

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Randomization 3 Arms

• 1) no Fluoride Varnish (FV)
• 2) FV once/year
• baseline, 12 months
• 3) FV twice/year
• baseline, 6, 12, 18 months
• Children followed for two years.

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METHODS

• Questionnaires administered to parents or
  caregivers in English, Cantonese or Spanish
• Whole saliva samples collected from children
• Traditional plating on selective media to
  determine levels of cariogenic bacteria mutans
  streptococcus (MS) and lactobacillus counts

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• Dental examinations conducted by Dr.
  Ramos-Gomez (blinded, no radiographs)
• Fluoride varnish applied by Dr. Jue to eligible,
  randomized children once or twice/year.
• Parental counseling provided by Dr. Jue or
  Ramos-Gomez (language dependent) to all families.

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RESULTS Demographics

• Total N 371 enrolled
• At CPHC, 95 Asian
• At SFGH, 87 Hispanic
• 53 girls
• Mean age 21 months (SD7.5)
• 77 of children, first dental visit
• 24 no dental insurance for child
• 12 caregivers had never seen a dentist
• 92 enrolled in WIC program

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Follow-up Rates(as of mid June )
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Baseline FindingsDifferent caries risk
indicators

• In the primarily Hispanic group, the Mother was
  more likely to have current or recent caries
  experience, and give the child a sweetened
  pacifier.
• In the primarily Chinese group, the Mother was
  less likely to brush the childs teeth or use a
  fluoride toothpaste when brushing the childs
  teeth.

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RECOMMENDATIONS

• Health promotion and caries prevention activities
  should be designed based on the culture and risks
  prevalent in a given community.
• All low SES communities are not the same, and
  one size fits all programs may be
  inappropriate.

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PROTOCOL DEVIATION

• Children participating in salivary sub-study
  between April 2001-Nov 1, 2001 had elevated
  fluoride levels 30 minutes after FV was applied
  (as expected).
• Children in this sub-study between Nov
  2001-August 22, 2002 DID NOT have elevated
  fluoride levels after application.
• Varnish was tested and found to be almost
  fluoride-free, placebo (21-30 ppm
  instead of 22,600 ppm)

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Modified Plans

• All parties notified Colgate (who supplied
  varnish), NIH, DSMB, UCSF IRB)
• Analysis plans revised and approved by DSMB.
• Many possible combinations for each 6, 12, or 18
  month visit (active dose, inactive dose, missed
  appt, scheduled)
• On average, eligible children will receive 1 or 2
  active doses instead of 2 or 4.

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DISCUSSION