Clinical Trial: Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: The risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. Currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. However, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. Since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.

Detailed Summary:
Sponsor: University of Campinas, Brazil

Current Primary Outcome: Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion [ Time Frame: 3 hours ]

Saliva will be collected before and up to 3 hours after ingestion of the toothpastes or negative control. Collections (during 3 min) will be made at 0 (immediately before ingestion), 15, 30, 45, 60, 120 and 180 min after ingestion.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum concentration of fluoride in saliva after toothpaste ingestion [ Time Frame: 3 hours ]
    Saliva collected up to 3 hours after the ingestion of toothpastes or negative control will be analyzed for fluoride concentration and the maximum concentration during this period will be recorded.
  • Urinary fluoride excretion (24-h) after toothpaste ingestion [ Time Frame: 48 hours ]
    Urine will be collected for the 24 hours preceeding the ingestion of the toothpastes or negative control and for the 24 hours after the ingestion. The difference in the amount of fluoride excreted in 24h urine samples, after or before the treatments, will be calculated.


Original Secondary Outcome: Same as current

Information By: University of Campinas, Brazil

Dates:
Date Received: March 30, 2012
Date Started: January 2011
Date Completion:
Last Updated: April 2, 2012
Last Verified: April 2012