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

NCT ID: NCT01589458

Last Updated: 2012-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Non-fluoride toothpaste

Group Type PLACEBO_COMPARATOR

Toothpaste

Intervention Type DRUG

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

NaF/SiO2 toothpaste

Group Type EXPERIMENTAL

Toothpaste

Intervention Type DRUG

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

MFP/CaCO3 toothpaste

Group Type EXPERIMENTAL

Toothpaste

Intervention Type DRUG

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

Interventions

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Toothpaste

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good general health
* Good oral health
* Normal salivary flow rate

Exclusion Criteria

* Use of systemic drugs that reduce salivary flow rate
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Livia Maria Andaló Tenuta

Assistant Professor, Biochemistry and Cariology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Livia MA Tenuta, PhD

Role: PRINCIPAL_INVESTIGATOR

Piracicaba Dental School, University of Campinas

Locations

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Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 15798817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22460314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21180793 (View on PubMed)

Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.

Reference Type BACKGROUND
PMID: 20857070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22182293 (View on PubMed)

Other Identifiers

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FOPBioq003

Identifier Type: -

Identifier Source: org_study_id

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