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

NCT ID: NCT01978041

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Meal prepared with non fluoridated water (<0.1 ppm F)

Group Type: EXPERIMENTAL

Meal prepared with non fluoridated water

Intervention Type: 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 (1 ppm F)

Group Type: EXPERIMENTAL

Meal prepared with fluoridated water

Intervention Type: 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 (<0.1 ppm F)

Group Type: EXPERIMENTAL

Non fluoridated water

Intervention Type: 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 (1 ppm F)

Group Type: EXPERIMENTAL

Fluoridated water

Intervention Type: OTHER

Ingestion of fluoridated water (1 ug F/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.

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

Group Type: EXPERIMENTAL

Meal prepared to provide a fluoride dose of 60 ug F/kg

Intervention Type: 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

Group Type: EXPERIMENTAL

Meal prepared to provide a fluoride dose of 120 ug F/kg

Intervention Type: 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.

Interventions

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).

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Fluoridated water

Ingestion of fluoridated water (1 ug F/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Livia Maria Andaló Tenuta

Associate Professor, Biochemistry and Cariology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livia MA Tenuta, PhD

Role: PRINCIPAL_INVESTIGATOR

Piracicaba Dental School, Unversity of Campinas

Locations

Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 23295625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16304442 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17589752 (View on PubMed)

Other Identifiers

FOPBioq004

Identifier Type: -

Identifier Source: org_study_id