Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fresh NaF/SiO2 toothpaste
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Drug: Fresh NaF/SiO2 toothpaste
Ingestion of 49.5 mg of a fresh toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.
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| Placebo Comparator: Purified water
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Drug: Purified water
Ingestion of 30 mL of purified water
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| Experimental: Aged NaF/SiO2 toothpaste
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Drug: Aged NaF/SiO2 toothpaste
Ingestion of 49.5 mg of a toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.
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| Experimental: Fresh MFP/CaCO3 toothpaste
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Drug: Fresh MFP/CaCO3 toothpaste
Ingestion of 31.9 mg of a fresh toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.
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| Experimental: Aged MFP/CaCO3 toothpaste
|
Drug: Aged MFP/CaCO3 toothpaste
Ingestion of 31.9 mg of a toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.
|
Outcome Measures
Primary Outcome Measures
- Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion [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.
Secondary Outcome Measures
- Maximum concentration of fluoride in saliva after toothpaste ingestion [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Good general health
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Good oral health
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Normal salivary flow rate
Exclusion Criteria:
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Gastric disorders
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Renal disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Piracicaba Dental School, University of Campinas | Piracicaba | SP | Brazil | 13414903 |
Sponsors and Collaborators
- University of Campinas, Brazil
Investigators
- Principal Investigator: Livia MA Tenuta, PhD, Piracicaba Dental School, University of Campinas
Study Documents (Full-Text)
None provided.More Information
Publications
- Cury JA, Del Fiol FS, Tenuta LM, Rosalen PL. Low-fluoride dentifrice and gastrointestinal fluoride absorption after meals. J Dent Res. 2005 Dec;84(12):1133-7.
- Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400.
- Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.
- FOPFBioavailability2011