Clinical trial NCT01978041: Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water
Official title: Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Dental Fluorosis
Keywords: pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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%.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve of plasma fluoride concentration versus time after water or food ingestion
timeFrame: 180 minutes
Secondary outcomes:
measure: Area under the curve of salivary fluoride concentration versus time after water or food ingestion
timeFrame: 180 minutes
measure: Maximum fluoride concentration in saliva after water or food ingestion
timeFrame: 180 minutes
measure: Maximum fluoride concentration in plasma after water or food ingestion
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, University of Campinas
state: São Paulo
Study officials:
affiliation: Piracicaba Dental School, Unversity of Campinas
name: Livia MA Tenuta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falcao 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.
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. doi: 10.1177/154405910508401208.
citation: 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. doi: 10.1590/s0034-89102006005000034. Portuguese.