Back to resultsFluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring toothpastes, saliva, dental caries, fluoride
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
Sites / Locations
- Piracicaba Dental School, University of Campinas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Non-fluoride toothpaste
NaF/SiO2 toothpaste
MFP/CaCO3 toothpaste
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes
Secondary Outcome Measures
Percentage of MFP hydrolyzed in saliva as a function of time
Full Information
NCT ID
NCT01589458
First Posted
April 29, 2012
Last Updated
May 1, 2012
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01589458
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
toothpastes, saliva, dental caries, fluoride
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-fluoride toothpaste
Arm Type
Placebo Comparator
Arm Title
NaF/SiO2 toothpaste
Arm Type
Experimental
Arm Title
MFP/CaCO3 toothpaste
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Toothpaste
Intervention Description
1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
Primary Outcome Measure Information:
Title
Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Percentage of MFP hydrolyzed in saliva as a function of time
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia MA Tenuta, PhD
Organizational Affiliation
Piracicaba Dental School, University of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15798817
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.
Results Reference
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PubMed Identifier
22460314
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.
Results Reference
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PubMed Identifier
21180793
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.
Results Reference
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PubMed Identifier
20857070
Citation
Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.
Results Reference
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PubMed Identifier
22182293
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.
Results Reference
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Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes
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