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Trial record 36 of 750 for:    Area Under Curve AND meal

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

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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

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%.

Condition or disease Intervention/treatment Phase
Dental Caries Dental Fluorosis Other: Meal prepared with non fluoridated water Other: Meal prepared with fluoridated water Other: Non fluoridated water Other: Fluoridated water Other: Meal prepared to provide a fluoride dose of 60 ug F/kg Other: Meal prepared to provide a fluoride dose of 120 ug F/kg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meal prepared with non fluoridated water (<0.1 ppm F) 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).

Experimental: Meal prepared with fluoridated water (1 ppm F) 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.

Experimental: Non fluoridated water (<0.1 ppm F) 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.

Experimental: Fluoridated water (1 ppm F) 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.

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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Maximum fluoride concentration in saliva after water or food ingestion [ Time Frame: 180 minutes ]
  3. Maximum fluoride concentration in plasma after water or food ingestion [ Time Frame: 180 minutes ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978041


Locations
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Brazil
Piracicaba Dental School, University of Campinas
Piracicaba, São Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Livia MA Tenuta, PhD Piracicaba Dental School, Unversity of Campinas

Publications:
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Responsible Party: Livia Maria Andaló Tenuta, Associate Professor, Biochemistry and Cariology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01978041     History of Changes
Other Study ID Numbers: FOPBioq004
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Livia Maria Andaló Tenuta, University of Campinas, Brazil:
pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries
Additional relevant MeSH terms:
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Dental Caries
Fluorosis, Dental
Fluoride Poisoning
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Poisoning
Chemically-Induced Disorders
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs