Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 28, 2013
October 1, 2013
1.9 years
April 30, 2012
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
30min
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).
8h
Secondary Outcomes (3)
Fluoride concentration in biofilm solid
30min
Fluoride concentration in saliva
30min
Amount of toothpaste ingested
January 2013 to July 2013
Study Arms (4)
Non-fluoride toothpaste
PLACEBO COMPARATORToothpaste 550 µg F/g (NaF/SiO2)
EXPERIMENTALToothpaste 1100 µg F/g (NaF/SiO2)
EXPERIMENTALToothpaste 1450 µg F/g (MFP/CaCO3)
EXPERIMENTALInterventions
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Eligibility Criteria
You may qualify if:
- Good general health
- Good oral health
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Piracicaba Dental School, University of Campinas
Piracicaba, São Paulo, 13414903, Brazil
Related Publications (8)
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.
PMID: 20662910BACKGROUNDLima 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.
PMID: 18042987BACKGROUNDCury 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.
PMID: 15798817BACKGROUNDPaes 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.
PMID: 14691117BACKGROUNDCury 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.
PMID: 12740543BACKGROUNDCury 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.
PMID: 15914990BACKGROUNDCury 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.
PMID: 21180793BACKGROUNDMartins 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.
PMID: 22163207BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Livia MA Tenuta, PhD
Piracicaba Dental School, University of Campinas
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Biochemistry and Cariology
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 2, 2012
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
October 28, 2013
Record last verified: 2013-10