- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978041
Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water
May 26, 2015 updated by: Livia Maria Andaló Tenuta, University of Campinas, Brazil
Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
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%.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Piracicaba, São Paulo, Brazil, 13414903
- Piracicaba Dental School, University of Campinas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meal prepared with non fluoridated water (<0.1 ppm F)
|
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)
|
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)
|
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)
|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
180 minutes
|
Maximum fluoride concentration in saliva after water or food ingestion
Time Frame: 180 minutes
|
180 minutes
|
|
Maximum fluoride concentration in plasma after water or food ingestion
Time Frame: 180 minutes
|
180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Livia MA Tenuta, PhD, Piracicaba Dental School, Unversity of Campinas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 25, 2013
First Submitted That Met QC Criteria
October 31, 2013
First Posted (Estimate)
November 7, 2013
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOPBioq004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Caries
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
3MUniversity of MichiganActive, not recruiting
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on Meal prepared with non fluoridated water
-
University of North Carolina, Chapel HillNational Institute of Dental and Craniofacial Research (NIDCR); Tulane UniversityRecruiting
-
Swiss Federal Institute of TechnologyUniversity of ZurichCompleted
-
University of LausanneUniversity of Lausanne HospitalsCompletedNormal SubjectsSwitzerland
-
Clinical Nutrition Research Center, Illinois Institute...Completed
-
University of TorontoCanadian Institutes of Health Research (CIHR)Completed
-
Charite University, Berlin, GermanyTerminatedInfluence of Espresso on Heart Rate VariabilityGermany
-
University of ChesterCompletedAnemia, Iron-DeficiencyUnited Kingdom
-
University of Illinois at ChicagoAbbott NutritionCompleted
-
University of MichiganFood and Drug Administration (FDA)CompletedLocal Drug Concentration in Gastrointestinal TractUnited States
-
Indonesia UniversityDr Cipto Mangunkusumo General Hospital; SEAMEO Regional Centre for Food and...CompletedObesity | Ghrelin | Appetite | Gut Hormones | PYY | VAS of Satiety | VAS of Hunger | GLP - 1Indonesia