Dental Caries Clinical Trial
Official title:
Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
Verified date | May 2015 |
Source | University of Campinas, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
The importance of fluoridated water to control caries is well recognized. Although the mode of action of fluoridated water is known (related to a slight increase in fluoride concentration in saliva/dental biofilm in individuals living in fluoridated areas), the kinetics of fluoride concentration in saliva after ingestion of food prepared with fluoridated water, either from fluoride remaining in the oral cavity after mastication, or from fluoride returning from salivary secretion is not known in details. Therefore, the aim of this study is to assess fluoride bioavailability after ingestion of food prepared with fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical Brazilian meal cooked with non-fluoridated water (<0.1 ppm F); b. a typical Brazilian meal cooked with fluoridated water (1 ppm F); c. non fluoridated water (<0.1 ppm F) and d. fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes after the ingestion, a blood sample will be collected by digital puncture, and a sample of unstimulated saliva will be collected. Fluoride concentration in the samples will be determined by an ion specific electrode adapted for microanalysis. Results will be analyzed by ANOVA, with significance limit of 5%.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion criteria: - Good general health - Good oral health - Normal salivary flow rate Exclusion criteria: - Gastric disorders - Renal disorders - Systemic diseases - Use of drugs that alter salivary flow rate/renal excretion |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Piracicaba Dental School, University of Campinas | Piracicaba | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Casarin RC, Fernandes DR, Lima-Arsati YB, Cury JA. [Fluoride concentrations in typical Brazilian foods and in infant foods]. Rev Saude Publica. 2007 Aug;41(4):549-56. Portuguese. — View Citation
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
Falcão A, Tenuta LM, Cury JA. Fluoride gastrointestinal absorption from Na2FPO3/CaCO3- and NaF/SiO2-based toothpastes. Caries Res. 2013;47(3):226-33. doi: 10.1159/000346006. Epub 2012 Dec 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve of plasma fluoride concentration versus time after water or food ingestion | A microsample of blood will be collected by digital puncture before and 5, 10, 15, 30, 45, 60, 120 and 180 min after treatments, to calculate the area under the curve of fluoride concentration in the plasma | 180 minutes | No |
Secondary | Area under the curve of salivary fluoride concentration versus time after water or food ingestion | A sample of unstimulated saliva will be collected by digital puncture before and 5, 10, 15, 30, 45, 60, 120 and 180 min after treatments, to calculate the area under the curve of fluoride concentration in saliva | 180 minutes | No |
Secondary | Maximum fluoride concentration in saliva after water or food ingestion | 180 minutes | No | |
Secondary | Maximum fluoride concentration in plasma after water or food ingestion | 180 minutes | No |
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