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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571050
Other study ID # FOPFBioavailability2011
Secondary ID
Status Completed
Phase Phase 1
First received March 30, 2012
Last updated April 2, 2012
Start date January 2011
Est. completion date December 2011

Study information

Verified date April 2012
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria:

- Good general health

- Good oral health

- Normal salivary flow rate

Exclusion Criteria:

- Gastric disorders

- Renal disorders

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Purified water
Ingestion of 30 mL of purified water
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.
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.
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.
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.

Locations

Country Name City State
Brazil Piracicaba Dental School, University of Campinas Piracicaba SP

Sponsors (1)

Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion 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. 3 hours No
Secondary Maximum concentration of fluoride in saliva after toothpaste ingestion 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. 3 hours No
Secondary Urinary fluoride excretion (24-h) after toothpaste ingestion 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. 48 hours No
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