Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Dental Caries Clinical Trial

Official title:

Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589991
• Other study ID #: FOPBioq002
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2012
• Last updated: October 25, 2013
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 4 Years

Eligibility

Inclusion Criteria:

• Good general health

• Good oral health

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries
• Dental Fluorosis
• Fluoride Poisoning
• Fluorosis, Dental

Intervention

Drug:
• Toothpaste
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, University of Campinas	Piracicaba	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Cury JA, Francisco SB, Simões 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. — View 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. — View Citation

Cury JA, Simões GS, Del Bel Cury AA, Gonçalves NC, Tabchoury CP. Effect of a calcium carbonate-based dentifrice on in situ enamel remineralization. Caries Res. 2005 May-Jun;39(3):255-7. — View 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. Epub 2005 Mar 18. Review. — View 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. Epub 2007 Nov 27. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	30min	No
Secondary	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.	30min	No
Secondary	Amount of toothpaste ingested	Determination of amount of toothpaste ingested after one simulated brushing.	January 2013 to July 2013	No