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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Livia Maria Andaló Tenuta, University of Campinas, Brazil

ClinicalTrials.gov Identifier:

NCT01589458

First received: April 29, 2012

Last updated: May 1, 2012

Last verified: April 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Dental Caries	Drug: Toothpaste	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay

Drug Information available for: Fluorine Fluoride

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:

Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of MFP hydrolyzed in saliva as a function of time [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]


Enrollment:	12
Study Start Date:	August 2011
Study Completion Date:	March 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Non-fluoride toothpaste	Drug: Toothpaste 1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
Experimental: NaF/SiO2 toothpaste	Drug: Toothpaste 1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
Experimental: MFP/CaCO3 toothpaste	Drug: Toothpaste 1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse

Eligibility


Ages Eligible for Study:	18 Years to 35 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Good general health
Good oral health
Normal salivary flow rate

Exclusion Criteria:

Use of systemic drugs that reduce salivary flow rate

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589458

Locations


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

Sponsors and Collaborators

University of Campinas, Brazil

Investigators


Principal Investigator:	Livia MA Tenuta, PhD	Piracicaba Dental School, University of Campinas

More Information

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. Epub 2005 Mar 18. Review.

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.

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.

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

Carrera CA, Giacaman RA, Muñoz-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.


Responsible Party:	Livia Maria Andaló Tenuta, Assistant Professor, Biochemistry and Cariology, University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT01589458 History of Changes
Other Study ID Numbers:	FOPBioq003
Study First Received:	April 29, 2012
Last Updated:	May 1, 2012
Health Authority:	Brazil: Ministry of Health

Keywords provided by University of Campinas, Brazil:


toothpastes saliva dental caries fluoride

Additional relevant MeSH terms:


Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases	Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

To Top