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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01978041
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Livia Maria Andaló Tenuta, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE October 25, 2013
First Posted Date  ICMJE November 7, 2013
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
Area under the curve of plasma fluoride concentration versus time after water or food ingestion [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
  • Area under the curve of salivary fluoride concentration versus time after water or food ingestion [ Time Frame: 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 [ Time Frame: 180 minutes ]
  • Maximum fluoride concentration in plasma after water or food ingestion [ Time Frame: 180 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water
Official Title  ICMJE Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
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%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Dental Caries
  • Dental Fluorosis
Intervention  ICMJE
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Meal prepared with non fluoridated water (<0.1 ppm F)
    Intervention: Other: Meal prepared with non fluoridated water
  • Experimental: Meal prepared with fluoridated water (1 ppm F)
    Intervention: Other: Meal prepared with fluoridated water
  • Experimental: Non fluoridated water (<0.1 ppm F)
    Intervention: Other: Non fluoridated water
  • Experimental: Fluoridated water (1 ppm F)
    Intervention: Other: Fluoridated water
  • Experimental: Pilot study: Meal providing a fluoride dose of 60 ug F/kg
    Intervention: Other: Meal prepared to provide a fluoride dose of 60 ug F/kg
  • Experimental: Pilot study: Meal providing a fluoride dose of 120 ug F/kg
    Intervention: Other: Meal prepared to provide a fluoride dose of 120 ug F/kg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01978041
Other Study ID Numbers  ICMJE FOPBioq004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Livia Maria Andaló Tenuta, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Livia MA Tenuta, PhD Piracicaba Dental School, Unversity of Campinas
PRS Account University of Campinas, Brazil
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP