Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water

NCT01978041 — Phase 1, Completed, 20 participants, University of Campinas, Brazil

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Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water

Registry	NCT01978041
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: double, prevention
Enrollment	20 (Actual)
Sponsor	University of Campinas, Brazil (Other)
Conditions	Dental Caries, Dental Fluorosis
Interventions	Meal prepared with non fluoridated water, Meal prepared with fluoridated water, Non fluoridated water, Fluoridated water, Meal prepared to provide a fluoride dose of 60 ug F/kg, Meal prepared to provide a fluoride dose of 120 ug F/kg (Other)
Dates	start 2013-01-01, primary completion 2013-03-01, completion 2013-12-01, first posted 2013-11-07, last updated 2015-05-28
Locations	1 site in Brazil

-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%.

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+Arms and interventions

Arm	Type	Interventions
Meal prepared with non fluoridated water (<0.1 ppm F)	Experimental	Other: Meal prepared with non fluoridated water
Meal prepared with fluoridated water (1 ppm F)	Experimental	Other: Meal prepared with fluoridated water
Non fluoridated water (<0.1 ppm F)	Experimental	Other: Non fluoridated water
Fluoridated water (1 ppm F)	Experimental	Other: Fluoridated water
Pilot study: Meal providing a fluoride dose of 60 ug F/kg	Experimental	Other: Meal prepared to provide a fluoride dose of 60 ug F/kg
Pilot study: Meal providing a fluoride dose of 120 ug F/kg	Experimental	Other: Meal prepared to provide a fluoride dose of 120 ug F/kg

Meal prepared with non fluoridated water (Other): Ingestion of a typical brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with purified water containing a fluoride dose of 0.8 ug of fluoride/kg body weight (resulting of the natural fluoride concentration in foods).
Meal prepared with fluoridated water (Other): Ingestion of a typical brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with fluoridated water (1 ug of fluoride/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.
Non fluoridated water (Other): Ingestion of purified water with addition of fluoride to provide a total intake of approximately 0.8 ug of fluoride/kg body weight, which represented the same fluoride ingestion dose of the experimental phase with meal prepared with non fluoridated water.
Fluoridated water (Other): Ingestion of fluoridated water (1 ug F/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.
Meal prepared to provide a fluoride dose of 60 ug F/kg (Other): Ingestion of a typical Brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with non-fluoridated water, with sodium fluoride solution added to the juice to provide a total intake of approximately 60 ug of fluoride/kg body weight.
Meal prepared to provide a fluoride dose of 120 ug F/kg (Other): Ingestion of a typical Brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with non-fluoridated water, with sodium fluoride solution added to the juice to provide a total intake of approximately 60 ug of fluoride/kg body weight.

+Outcome measures

Primary outcomes

Area under the curve of plasma fluoride concentration versus time after water or food ingestion [180 minutes]: 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

Secondary outcomes

Area under the curve of salivary fluoride concentration versus time after water or food ingestion [180 minutes]: 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
Maximum fluoride concentration in saliva after water or food ingestion [180 minutes]
Maximum fluoride concentration in plasma after water or food ingestion [180 minutes]

+Eligibility

Sex: All, ages: 18 Years to 35 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Piracicaba Dental School, University of Campinas	Piracicaba, São Paulo	Brazil

+Publications

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. PMID 23295625
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. PMID 16304442
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. PMID 17589752

+Investigators

Livia MA Tenuta, PhD, Principal investigator, Piracicaba Dental School, Unversity of Campinas

My Notes

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