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

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ClinicalTrials.gov Identifier: NCT01589458
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):
Livia Maria Andaló Tenuta, University of Campinas, Brazil

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Toothpaste Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Fluoride

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Percentage of MFP hydrolyzed in saliva as a function of time [ Time Frame: 60 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589458


Locations
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Brazil
Piracicaba Dental School, University of Campinas
Piracicaba, São Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Livia MA Tenuta, PhD Piracicaba Dental School, University of Campinas
More Information
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Publications:

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Responsible Party: Livia Maria Andaló Tenuta, Assistant Professor, Biochemistry and Cariology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01589458    
Other Study ID Numbers: FOPBioq003
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012
Keywords provided by Livia Maria Andaló Tenuta, University of Campinas, Brazil:
toothpastes
saliva
dental caries
fluoride
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases