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

Dental Caries Clinical Trial

Official title:

Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589458
• Other study ID #: FOPBioq003
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2012
• Last updated: May 1, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Good general health

• Good oral health

• Normal salivary flow rate

Exclusion Criteria:

• Use of systemic drugs that reduce salivary flow rate

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, University of Campinas	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes		60 minutes	No
Secondary	Percentage of MFP hydrolyzed in saliva as a function of time		60 minutes	No