Clinical trial NCT01589991: Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Official title: Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Dental Fluorosis
Keywords: toothpastes
bioavailability
sodium fluoride
monofluorphosphate
low-fluoride
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Good oral health

Primary outcomes:
measure: Fluoride concentration in biofilm fluid
timeFrame: 30min
measure: Urinary fluoride excretion
timeFrame: 8h
Secondary outcomes:
measure: Fluoride concentration in biofilm solid
timeFrame: 30min
measure: Fluoride concentration in saliva
timeFrame: 30min
measure: Amount of toothpaste ingested
timeFrame: January 2013 to July 2013
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, University of Campinas
state: Sao Paulo
Study officials:
affiliation: Piracicaba Dental School, University of Campinas
name: Livia MA Tenuta, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.