Back to resultsAnticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Primary Purpose
Dental Caries, Dental Fluorosis
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, bioavailability, sodium fluoride, monofluorphosphate, low-fluoride
Eligibility Criteria
Inclusion Criteria:
- Good general health
- Good oral health
Sites / Locations
- Piracicaba Dental School, University of Campinas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Non-fluoride toothpaste
Toothpaste 550 µg F/g (NaF/SiO2)
Toothpaste 1100 µg F/g (NaF/SiO2)
Toothpaste 1450 µg F/g (MFP/CaCO3)
Arm Description
Outcomes
Primary Outcome Measures
Fluoride concentration in biofilm fluid
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis.
Urinary fluoride excretion
Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine).
Secondary Outcome Measures
Fluoride concentration in biofilm solid
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm solids will be determined after acid extraction using a fluoride electrode adapted for microanalysis.
Fluoride concentration in saliva
Non-stimulated saliva will be collected at 0 (immediately before toothbrushing), 7, 15 and 30 min after toothbrushing. Fluoride concentration in saliva will be determined by a ion-specific fluoride electrode, adapted for microanalysis.
Amount of toothpaste ingested
Determination of amount of toothpaste ingested after one simulated brushing.
Full Information
NCT ID
NCT01589991
First Posted
April 30, 2012
Last Updated
October 25, 2013
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01589991
Brief Title
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Official Title
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (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
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Fluorosis
Keywords
toothpastes, bioavailability, sodium fluoride, monofluorphosphate, low-fluoride
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-fluoride toothpaste
Arm Type
Placebo Comparator
Arm Title
Toothpaste 550 µg F/g (NaF/SiO2)
Arm Type
Experimental
Arm Title
Toothpaste 1100 µg F/g (NaF/SiO2)
Arm Type
Experimental
Arm Title
Toothpaste 1450 µg F/g (MFP/CaCO3)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Toothpaste
Intervention Description
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Primary Outcome Measure Information:
Title
Fluoride concentration in biofilm fluid
Description
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis.
Time Frame
30min
Title
Urinary fluoride excretion
Description
Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine).
Time Frame
8h
Secondary Outcome Measure Information:
Title
Fluoride concentration in biofilm solid
Description
Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm solids will be determined after acid extraction using a fluoride electrode adapted for microanalysis.
Time Frame
30min
Title
Fluoride concentration in saliva
Description
Non-stimulated saliva will be collected at 0 (immediately before toothbrushing), 7, 15 and 30 min after toothbrushing. Fluoride concentration in saliva will be determined by a ion-specific fluoride electrode, adapted for microanalysis.
Time Frame
30min
Title
Amount of toothpaste ingested
Description
Determination of amount of toothpaste ingested after one simulated brushing.
Time Frame
January 2013 to July 2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good general health
Good oral health
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
Study Chair
Facility Information:
Facility Name
Piracicaba Dental School, University of Campinas
City
Piracicaba
State/Province
Sao Paulo
ZIP/Postal Code
13414903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
20662910
Citation
Cury JA, do Amaral RC, Tenuta LM, Del Bel Cury AA, Tabchoury CP. Low-fluoride toothpaste and deciduous enamel demineralization under biofilm accumulation and sucrose exposure. Eur J Oral Sci. 2010 Aug;118(4):370-5. doi: 10.1111/j.1600-0722.2010.00745.x.
Results Reference
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PubMed Identifier
18042987
Citation
Lima TJ, Ribeiro CC, Tenuta LM, Cury JA. Low-fluoride dentifrice and caries lesion control in children with different caries experience: a randomized clinical trial. Caries Res. 2008;42(1):46-50. doi: 10.1159/000111749. Epub 2007 Nov 27.
Results Reference
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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
background
PubMed Identifier
14691117
Citation
Paes Leme AF, Dalcico R, Tabchoury CP, Del Bel Cury AA, Rosalen PL, Cury JA. In situ effect of frequent sucrose exposure on enamel demineralization and on plaque composition after APF application and F dentifrice use. J Dent Res. 2004 Jan;83(1):71-5. doi: 10.1177/154405910408300114.
Results Reference
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PubMed Identifier
12740543
Citation
Cury JA, Francisco SB, Simoes GS, Del Bel Cury AA, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on enamel demineralization in situ. Caries Res. 2003 May-Jun;37(3):194-9. doi: 10.1159/000070444.
Results Reference
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PubMed Identifier
15914990
Citation
Cury JA, Simoes GS, Del Bel Cury AA, Goncalves NC, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on in situ enamel remineralization. Caries Res. 2005 May-Jun;39(3):255-7. doi: 10.1159/000084807.
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
22163207
Citation
Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.
Results Reference
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Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
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