Dental CariesPhase 1NCT01589991
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
A Phase 1 study testing Toothpaste in people with Dental Caries and Dental Fluorosis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an… Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Fluorosis
- What is being tested?
- Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jul 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Good general health
- Good oral health
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, University of Campinas
Piracicaba, São Paulo, 13414903
About this study
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.
- Conditions
- Dental Caries, Dental Fluorosis
- Being tested
- Toothpaste
- Keywords
- toothpastes, bioavailability, sodium fluoride, monofluorphosphate, low-fluoride
- 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.
ToothpasteDrug
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
| Study group | Role | What they receive |
|---|---|---|
| Non-fluoride toothpaste | Placebo comparator | Not described Receives: Drug: Toothpaste |
| Toothpaste 550 µg F/g (NaF/SiO2) | Experimental | Not described Receives: Drug: Toothpaste |
| Toothpaste 1100 µg F/g (NaF/SiO2) | Experimental | Not described Receives: Drug: Toothpaste |
| Toothpaste 1450 µg F/g (MFP/CaCO3) | Experimental | Not described Receives: Drug: Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoride concentration in biofilm fluid
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis.
Measured: 30min
Urinary fluoride excretion
Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine).
Measured: 8h
Secondary outcomes (3)
Fluoride concentration in biofilm solid
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm solids will be determined after acid extraction using a fluoride electrode adapted for microanalysis.
Measured: 30min
Fluoride concentration in saliva
Non-stimulated saliva will be collected at 0 (immediately before toothbrushing), 7, 15 and 30 min after toothbrushing. Fluoride concentration in saliva will be determined by a ion-specific fluoride electrode, adapted for microanalysis.
Measured: 30min
Amount of toothpaste ingested
Determination of amount of toothpaste ingested after one simulated brushing.
Measured: January 2013 to July 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 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, Study chair, Piracicaba Dental School, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589991
- Sponsor's protocol ID
- FOPBioq002
- Status last verified
- Oct 2013
- First submitted
- 30 Apr 2012
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cury JA, do Amaral RC, Tenuta LM, Del Bel Cury AA, Tabchoury CP. Low-fluoride toothpaste and deciduous enamel demineralization under biofilm accumulation and sucrose exposure. Eur J Oral Sci. 2010 Aug;118(4):370-5. doi: 10.1111/j.1600-0722.2010.00745.x.
PubMed 20662910Lima TJ, Ribeiro CC, Tenuta LM, Cury JA. Low-fluoride dentifrice and caries lesion control in children with different caries experience: a randomized clinical trial. Caries Res. 2008;42(1):46-50. doi: 10.1159/000111749. Epub 2007 Nov 27.
PubMed 18042987Cury JA, Tenuta LM, Ribeiro CC, Paes Leme AF. The importance of fluoride dentifrices to the current dental caries prevalence in Brazil. Braz Dent J. 2004;15(3):167-74. doi: 10.1590/s0103-64402004000300001. Epub 2005 Mar 18.
PubMed 15798817Paes Leme AF, Dalcico R, Tabchoury CP, Del Bel Cury AA, Rosalen PL, Cury JA. In situ effect of frequent sucrose exposure on enamel demineralization and on plaque composition after APF application and F dentifrice use. J Dent Res. 2004 Jan;83(1):71-5. doi: 10.1177/154405910408300114.
PubMed 14691117Cury JA, Francisco SB, Simoes GS, Del Bel Cury AA, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on enamel demineralization in situ. Caries Res. 2003 May-Jun;37(3):194-9. doi: 10.1159/000070444.
PubMed 12740543Cury JA, Simoes GS, Del Bel Cury AA, Goncalves NC, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on in situ enamel remineralization. Caries Res. 2005 May-Jun;39(3):255-7. doi: 10.1159/000084807.
PubMed 15914990Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. doi: 10.1590/s0103-64402010000500003.
PubMed 21180793Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.
PubMed 22163207
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
- ClinicalTrials.gov ID
- NCT01589991
- Acronym / sponsor ID
- FOPBioq002
- Conditions
- Dental Caries, Dental Fluorosis
- Keywords
- toothpastes, bioavailability, sodium fluoride, monofluorphosphate, low-fluoride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 May 2012 (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.
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-fluoride toothpaste | Placebo comparator | Drug: Toothpaste |
| Toothpaste 550 µg F/g (NaF/SiO2) | Experimental | Drug: Toothpaste |
| Toothpaste 1100 µg F/g (NaF/SiO2) | Experimental | Drug: Toothpaste |
| Toothpaste 1450 µg F/g (MFP/CaCO3) | Experimental | Drug: Toothpaste |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Good general health
- Good oral health
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ToothpasteThe volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day. | Drug | Non-fluoride toothpaste, Toothpaste 1100 µg F/g (NaF/SiO2), Toothpaste 1450 µg F/g (MFP/CaCO3), Toothpaste 550 µg F/g (NaF/SiO2) |
Primary outcome
Fluoride concentration in biofilm fluid
Time frame: 30min
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis.
Urinary fluoride excretion
Time frame: 8h
Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine).
3 secondary outcomes
Fluoride concentration in biofilm solid
Time frame: 30min
Fluoride concentration in saliva
Time frame: 30min
Amount of toothpaste ingested
Time frame: January 2013 to July 2013
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 Oct 2013.
- Background: PubMed 20662910Cury JA, do Amaral RC, Tenuta LM, Del Bel Cury AA, Tabchoury CP. Low-fluoride toothpaste and deciduous enamel demineralization under biofilm accumulation and sucrose exposure. Eur J Oral Sci. 2010 Aug;118(4):370-5. doi: 10.1111/j.1600-0722.2010.00745.x.
- Background: PubMed 18042987Lima TJ, Ribeiro CC, Tenuta LM, Cury JA. Low-fluoride dentifrice and caries lesion control in children with different caries experience: a randomized clinical trial. Caries Res. 2008;42(1):46-50. doi: 10.1159/000111749. Epub 2007 Nov 27.
- Background: PubMed 15798817Cury JA, Tenuta LM, Ribeiro CC, Paes Leme AF. The importance of fluoride dentifrices to the current dental caries prevalence in Brazil. Braz Dent J. 2004;15(3):167-74. doi: 10.1590/s0103-64402004000300001. Epub 2005 Mar 18.
- Background: PubMed 14691117Paes Leme AF, Dalcico R, Tabchoury CP, Del Bel Cury AA, Rosalen PL, Cury JA. In situ effect of frequent sucrose exposure on enamel demineralization and on plaque composition after APF application and F dentifrice use. J Dent Res. 2004 Jan;83(1):71-5. doi: 10.1177/154405910408300114.
- Background: PubMed 12740543Cury JA, Francisco SB, Simoes GS, Del Bel Cury AA, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on enamel demineralization in situ. Caries Res. 2003 May-Jun;37(3):194-9. doi: 10.1159/000070444.
- Background: PubMed 15914990Cury JA, Simoes GS, Del Bel Cury AA, Goncalves NC, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on in situ enamel remineralization. Caries Res. 2005 May-Jun;39(3):255-7. doi: 10.1159/000084807.
- Background: PubMed 21180793Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. doi: 10.1590/s0103-64402010000500003.
- Background: PubMed 22163207Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.
- Related InfoLink 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 study chair
Piracicaba Dental School, University 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 Toothpaste 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 2 inclusion and 0 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 Oct 2013. 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. Some participants in this study may receive a placebo. 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?
Fluoride concentration in biofilm fluid (time frame: 30min). The study lists 2 primary outcomes in all. 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 NCT01589991, which also lists 8 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 Oct 2013.