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Clinical Trials/NCT01589458
NCT01589458CompletedPhase 1

Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes

University of Campinas, Brazil1 site in 1 country12 target enrollmentStarted: August 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Use of systemic drugs that reduce salivary flow rate

Arms & Interventions

Non-fluoride toothpaste

Placebo Comparator

Intervention: Toothpaste (Drug)

NaF/SiO2 toothpaste

Experimental

Intervention: Toothpaste (Drug)

MFP/CaCO3 toothpaste

Experimental

Intervention: Toothpaste (Drug)

Outcomes

Primary Outcomes

Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes

Time Frame: 60 minutes

Secondary Outcomes

  • Percentage of MFP hydrolyzed in saliva as a function of time(60 minutes)

Investigators

Sponsor
University of Campinas, Brazil
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Livia Maria Andaló Tenuta

Assistant Professor, Biochemistry and Cariology

University of Campinas, Brazil

Study Sites (1)

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