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

NCT01978041 | Completed Phase 1

• 1 other identifier: FOPBioq004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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%.

Conditions

Dental Caries; Dental Fluorosis

Keywords

pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Area under the curve of salivary fluoride concentration versus time after water or food ingestion

  180 minutes

• Maximum fluoride concentration in saliva after water or food ingestion

  180 minutes

• Maximum fluoride concentration in plasma after water or food ingestion

  180 minutes

Study Arms (6)

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

Interventions

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 non fluoridated water (<0.1 ppm F)

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.

Meal prepared with fluoridated water (1 ppm F)

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.

Non fluoridated water (<0.1 ppm F)

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.

Fluoridated water (1 ppm F)

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.

Pilot study: Meal providing a fluoride dose of 60 ug F/kg

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.

Pilot study: Meal providing a fluoride dose of 120 ug F/kg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• Good oral health
• Normal salivary flow rate

You may not qualify if:

• Gastric disorders
• Renal disorders
• Systemic diseases
• Use of drugs that alter salivary flow rate/renal excretion

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, 13414903, Brazil

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Fluorosis, Dental

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Livia MA Tenuta, PhD

  Piracicaba Dental School, Unversity of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Biochemistry and Cariology

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 7, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BR (1)