Clinical trial NCT01589458: Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes
Official title: Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Keywords: toothpastes
saliva
dental caries
fluoride
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Use of systemic drugs that reduce salivary flow rate

Primary outcomes:
measure: Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes
timeFrame: 60 minutes
Secondary outcomes:
measure: Percentage of MFP hydrolyzed in saliva as a function of time
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, University of Campinas
state: São Paulo
Study officials:
affiliation: Piracicaba Dental School, University of Campinas
name: Livia MA Tenuta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1590/s0103-64402004000300001. Epub 2005 Mar 18.
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. doi: 10.1590/s0103-64402012000100008.
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. doi: 10.1590/s0103-64402010000500003.
citation: Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.
citation: 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.