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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978041
• Other study ID #: FOPBioq004
• Status: Completed
• Phase: Phase 1
• First received: October 25, 2013
• Last updated: May 26, 2015
• Start date: January 2013
• Est. completion date: December 2013

Study information

• 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

Clinical Trial 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%.

Recruitment information / eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Fluorosis
• Fluorosis, Dental

Intervention

Other:
• Meal prepared with non fluoridated water
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
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
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
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
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
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

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