Dental CariesPhase 1NCT01589458

Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes

A Phase 1 study testing Toothpaste in people with Dental Caries, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: Toothpaste
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteBrazil
Study dates: Aug 2011to Mar 2012
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

Use of systemic drugs that reduce salivary flow rate

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Piracicaba Dental School, University of Campinas
Piracicaba, São Paulo, 13414903

Other trials in Brazil

About this study

Official title: Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes

Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based toothpastes, the present study aim to evaluate F availability in saliva after use of the top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using an ion selective electrode.

Conditions: Dental Caries
Being tested: Toothpaste
Keywords: toothpastes, saliva, dental caries, fluoride
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ToothpasteDrug
1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse

Study groups in NCT01589458
Study group	Role	What they receive
Non-fluoride toothpaste	Placebo comparator	Not described Receives: Drug: Toothpaste
NaF/SiO2 toothpaste	Experimental	Not described Receives: Drug: Toothpaste
MFP/CaCO3 toothpaste	Experimental	Not described Receives: Drug: Toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes
Measured: 60 minutes

Secondary outcomes (1)

Percentage of MFP hydrolyzed in saliva as a function of time
Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Mar 2012

First posted2 May 2012 (estimated)
Study startAug 2011
Primary completionFeb 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01589458
Sponsor's protocol ID: FOPBioq003
Status last verified: Apr 2012
First submitted: 29 Apr 2012
Last updated: 2 May 2012
Results posted: No
Data monitoring committee: No

Publications

Cury 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 15798817
Ricomini Filho AP, Tenuta LM, Fernandes FS, Calvo AF, Kusano SC, Cury JA. Fluoride concentration in the top-selling Brazilian toothpastes purchased at different regions. Braz Dent J. 2012;23(1):45-8. doi: 10.1590/s0103-64402012000100008.
PubMed 22460314
Cury 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 21180793
Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.
PubMed 20857070
Carrera CA, Giacaman RA, Munoz-Sandoval C, Cury JA. Total and soluble fluoride content in commercial dentifrices in Chile. Acta Odontol Scand. 2012 Dec;70(6):583-8. doi: 10.3109/00016357.2011.640287. Epub 2011 Dec 20.
PubMed 22182293

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes
ClinicalTrials.gov ID: NCT01589458
Acronym / sponsor ID: FOPBioq003
Conditions: Dental Caries
Keywords: toothpastes, saliva, dental caries, fluoride
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of Campinas, BrazilUniversity, hospital or other
Study start: Aug 2011
Primary completion: Feb 2012 (actual)
Study completion: Mar 2012 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Non-fluoride toothpaste	Placebo comparator	Drug: Toothpaste
NaF/SiO2 toothpaste	Experimental	Drug: Toothpaste
MFP/CaCO3 toothpaste	Experimental	Drug: Toothpaste

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 (1 listed)

Use of systemic drugs that reduce salivary flow rate

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
Toothpaste1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse	Drug	MFP/CaCO3 toothpaste, NaF/SiO2 toothpaste, Non-fluoride toothpaste

Primary outcome

Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes
Time frame: 60 minutes

1 secondary outcome

Percentage of MFP hydrolyzed in saliva as a function of time
Time frame: 60 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 2 May 2012.
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 22460314Ricomini Filho AP, Tenuta LM, Fernandes FS, Calvo AF, Kusano SC, Cury JA. Fluoride concentration in the top-selling Brazilian toothpastes purchased at different regions. Braz Dent J. 2012;23(1):45-8. doi: 10.1590/s0103-64402012000100008.
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 20857070Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.
Background: PubMed 22182293Carrera CA, Giacaman RA, Munoz-Sandoval C, Cury JA. Total and soluble fluoride content in commercial dentifrices in Chile. Acta Odontol Scand. 2012 Dec;70(6):583-8. doi: 10.3109/00016357.2011.640287. Epub 2011 Dec 20.
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, 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, 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 1 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 2 May 2012. 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?

Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes (time frame: 60 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 NCT01589458, which also lists 5 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 2 May 2012.