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

Primary Purpose

Dental Caries, Dental Fluorosis

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
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
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Piracicaba Dental School, University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Meal prepared with fluoridated water (1 ppm F)

Non fluoridated water (<0.1 ppm F)

Fluoridated water (1 ppm F)

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

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Maximum fluoride concentration in saliva after water or food ingestion
Maximum fluoride concentration in plasma after water or food ingestion

Full Information

First Posted
October 25, 2013
Last Updated
May 26, 2015
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01978041
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Fluorosis
Keywords
pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meal prepared with non fluoridated water (<0.1 ppm F)
Arm Type
Experimental
Arm Title
Meal prepared with fluoridated water (1 ppm F)
Arm Type
Experimental
Arm Title
Non fluoridated water (<0.1 ppm F)
Arm Type
Experimental
Arm Title
Fluoridated water (1 ppm F)
Arm Type
Experimental
Arm Title
Pilot study: Meal providing a fluoride dose of 60 ug F/kg
Arm Type
Experimental
Arm Title
Pilot study: Meal providing a fluoride dose of 120 ug F/kg
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Meal prepared with non fluoridated water
Intervention Description
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
Intervention Name(s)
Meal prepared with fluoridated water
Intervention Description
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
Intervention Name(s)
Non fluoridated water
Intervention Description
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
Intervention Name(s)
Fluoridated water
Intervention Description
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
Intervention Name(s)
Meal prepared to provide a fluoride dose of 60 ug F/kg
Intervention Description
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
Intervention Name(s)
Meal prepared to provide a fluoride dose of 120 ug F/kg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the curve of plasma fluoride concentration versus time after water or food ingestion
Description
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
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Area under the curve of salivary fluoride concentration versus time after water or food ingestion
Description
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
Time Frame
180 minutes
Title
Maximum fluoride concentration in saliva after water or food ingestion
Time Frame
180 minutes
Title
Maximum fluoride concentration in plasma after water or food ingestion
Time Frame
180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia MA Tenuta, PhD
Organizational Affiliation
Piracicaba Dental School, Unversity of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23295625
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.
Results Reference
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PubMed Identifier
16304442
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.
Results Reference
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PubMed Identifier
17589752
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.
Results Reference
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Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water

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