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

Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Drug: Toothpaste

• Registration Number: NCT01589458
• Lead Sponsor: University of Campinas, Brazil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-29
• Study First Submitted QC: 2012-05-01
• Last Update Submitted: 2012-05-01
• Study First Posted: 2012-05-02
• Last Update Posted: 2012-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-fluoride toothpaste	Toothpaste	-
NaF/SiO2 toothpaste	Toothpaste	-
MFP/CaCO3 toothpaste	Toothpaste	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of MFP hydrolyzed in saliva as a function of time	60 minutes

Trial Locations

Locations (1)

Piracicaba Dental School, University of Campinas; 🇧🇷 Piracicaba, São Paulo, Brazil