Data and Safety Monitoring Board January 27, 2004

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Data and Safety Monitoring Board January 27, 2004

• Prevention of Early Childhood Caries Using
  Fluoride Varnish
• USDHHS NIH/NIDCR P60DE13058 U54DE142501

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Enrollment and Retention

• We enrolled 376 children, mean age 1.3 years
• Children were randomized to 3 groups
• (n124-126 / group)
• Last child due for last visit on August 1, 2004
• Anticipated 24-month retention rate 50

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Retention Rates at Follow-up
(excludes those w/ caries at 12 months)
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Timing of Follow-up Visits

• Some children thought lost to follow-up are
  coming for Headstart dental exams.
• Children do not always come for appointments
  during the planned window of time for a
  particular visit type.
• Some protocol deviations are due to unscheduled
  visits at different timepoints.
• Timing of 24-month visit is most critical.
• May be affected by closure of San Francisco
  General Hospital Family Dental Center.

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Safety and Quality

• No adverse events.
• Protocol deviations do not affect safety.
• Intra-reliability measures for clinical exam (for
  child) and salivary assays (for adults) are
  favorable.
• Except for baseline salivary assays, there are
  few missing records for participants with visits.
  
• Children seen and children due but not seen for
  12- and 24-month visits are similar with respect
  to most demographic variables.

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Fluoride Varnish InterventionActive fluoride
applications (to 12/03)
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Frequency Distribution of Active Fluoride
Applications (to Dec 2003)
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Clinical Outcomes(through December 2003)
Children with caries at 12-months discontinued
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Distribution of LB count by Visit and Integer
(log10LB1)
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Distribution of MS count by Visit and Integer
(log10LB1)
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Distribution of Fluoride Level (ppm) by Visit
Type
Missing insufficient volume Includes
assays below 0.02 ppm limit of detection
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Salivary Fluoride Levels(n21)
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Salivary Fluoride Study

• At 2 hours, levels remained elevated, 20 had
  returned to pre-FV baseline.
• At 1 week, 89 had returned to baseline.
• F levels were not correlated (Spearman r) with
  age, weight or teeth at any of the 4 timepoints
  (all p gt0.20).

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Enrollment of Moms of Children With and Without
Caries

• 41 (57) of 72 women have been enrolled.
• Majority enrolled are in group of women with
  caries-free children.
• Fewer children with caries have been seen, thus
  fewer Moms eligible in this group.

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Future Plans

• Presentations at IADR meeting
• Complete data collection this summer
• Request P60 carry-over funds for 1 year
• Data Analysis
• intent to treat
• actual active applications received
• revised analytical plans presented last winter.
• Report writing, presentations, publications
• Follow-up with Colgate