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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Livia Maria Andaló Tenuta, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01589458
First received: April 29, 2012
Last updated: May 1, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Dental Caries
Drug: Toothpaste
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of MFP hydrolyzed in saliva as a function of time [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01589458

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

Additional Information:
Publications:
Responsible Party: Livia Maria Andaló Tenuta, Assistant Professor, Biochemistry and Cariology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01589458     History of Changes
Other Study ID Numbers: FOPBioq003
Study First Received: April 29, 2012
Last Updated: May 1, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Campinas, Brazil:
toothpastes
saliva
dental caries
fluoride

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014