Dental CariesPhase 1NCT01978041
Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water
A Phase 1 study testing Meal prepared with non fluoridated water, Meal prepared with fluoridated water and Non fluoridated water in people with Dental Caries and Dental Fluorosis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Fluorosis
- What is being tested?
- Meal prepared with non fluoridated water, Meal prepared with fluoridated water and Non fluoridated water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- Good oral health
- Normal salivary flow rate
Who cannot join
- Gastric disorders
- Renal disorders
- Systemic diseases
- Use of drugs that alter salivary flow rate/renal excretion
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, University of Campinas
Piracicaba, São Paulo, 13414903
About this study
Official title: 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%.
- Conditions
- Dental Caries, Dental Fluorosis
- Being tested
- 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
- Keywords
- pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries
- Medical subject headings
- Dental Caries, Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal prepared with non fluoridated waterOther
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 waterOther
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 waterOther
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 waterOther
Ingestion of fluoridated water (1 ug F/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.
Meal prepared to provide a fluoride dose of 60 ug F/kgOther
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.
Meal prepared to provide a fluoride dose of 120 ug F/kgOther
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 group | Role | What they receive |
|---|---|---|
| Meal prepared with non fluoridated water (<0.1 ppm F) | Experimental | Not described Receives: Other: Meal prepared with non fluoridated water |
| Meal prepared with fluoridated water (1 ppm F) | Experimental | Not described Receives: Other: Meal prepared with fluoridated water |
| Non fluoridated water (<0.1 ppm F) | Experimental | Not described Receives: Other: Non fluoridated water |
| Fluoridated water (1 ppm F) | Experimental | Not described Receives: Other: Fluoridated water |
| Pilot study: Meal providing a fluoride dose of 60 ug F/kg | Experimental | Not described Receives: Other: Meal prepared to provide a fluoride dose of 60 ug F/kg |
| Pilot study: Meal providing a fluoride dose of 120 ug F/kg | Experimental | Not described Receives: Other: Meal prepared to provide a fluoride dose of 120 ug F/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 minutes
Secondary outcomes (3)
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
Measured: 180 minutes
Maximum fluoride concentration in saliva after water or food ingestion
Measured: 180 minutes
Maximum fluoride concentration in plasma after water or food ingestion
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Maria Andaló Tenuta, University of Campinas, Brazil
- Investigators
- Livia MA Tenuta, PhD, Principal investigator, Piracicaba Dental School, Unversity of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978041
- Sponsor's protocol ID
- FOPBioq004
- Status last verified
- May 2015
- First submitted
- 25 Oct 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23295625Cury 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.
PubMed 16304442Casarin 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.
PubMed 17589752
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
- ClinicalTrials.gov ID
- NCT01978041
- Acronym / sponsor ID
- FOPBioq004
- Conditions
- Dental Caries, Dental Fluorosis
- Keywords
- pharmacokinetics, saliva, plasma, fluoride, dental fluorosis, dental caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Meal prepared with non fluoridated water (<0.1 ppm F) | Experimental | Other: Meal prepared with non fluoridated water |
| Meal prepared with fluoridated water (1 ppm F) | Experimental | Other: Meal prepared with fluoridated water |
| Non fluoridated water (<0.1 ppm F) | Experimental | Other: Non fluoridated water |
| Fluoridated water (1 ppm F) | Experimental | Other: Fluoridated water |
| Pilot study: Meal providing a fluoride dose of 60 ug F/kg | Experimental | Other: Meal prepared to provide a fluoride dose of 60 ug F/kg |
| Pilot study: Meal providing a fluoride dose of 120 ug F/kg | Experimental | Other: Meal prepared to provide a fluoride dose of 120 ug F/kg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health
- Good oral health
- Normal salivary flow rate
Key exclusion criteria (4 listed)
- Gastric disorders
- Renal disorders
- Systemic diseases
- Use of drugs that alter salivary flow rate/renal excretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal prepared with non fluoridated waterIngestion 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 non fluoridated water (<0.1 ppm F) |
| Meal prepared with fluoridated waterIngestion 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 | Meal prepared with fluoridated water (1 ppm F) |
| Non fluoridated waterIngestion 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 | Non fluoridated water (<0.1 ppm F) |
| Fluoridated waterIngestion of fluoridated water (1 ug F/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight. | Other | Fluoridated water (1 ppm F) |
| Meal prepared to provide a fluoride dose of 60 ug F/kgIngestion 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 | Pilot study: Meal providing a fluoride dose of 60 ug F/kg |
| Meal prepared to provide a fluoride dose of 120 ug F/kgIngestion 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 | Pilot study: Meal providing a fluoride dose of 120 ug F/kg |
Primary outcome
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
3 secondary outcomes
Area under the curve of salivary fluoride concentration versus time after water or food ingestion
Time frame: 180 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 23295625Falcao 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.
- Background: PubMed 16304442Cury 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.
- Background: PubMed 17589752Casarin 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.
- Research facilitiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livia MA Tenuta, PhD principal investigator
Piracicaba Dental School, Unversity of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meal prepared with non fluoridated water, Meal prepared with fluoridated water and Non fluoridated water in people with Dental Caries and Dental Fluorosis, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of plasma fluoride concentration versus time after water or food ingestion (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01978041, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.