Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

NCT ID: NCT01589991

Last Updated: 2013-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries Dental Fluorosis

Keywords

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toothpastes bioavailability sodium fluoride monofluorphosphate low-fluoride

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Non-fluoride toothpaste

Group Type PLACEBO_COMPARATOR

Toothpaste

Intervention Type DRUG

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

Toothpaste 550 µg F/g (NaF/SiO2)

Group Type EXPERIMENTAL

Toothpaste

Intervention Type DRUG

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

Toothpaste 1100 µg F/g (NaF/SiO2)

Group Type EXPERIMENTAL

Toothpaste

Intervention Type DRUG

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

Toothpaste 1450 µg F/g (MFP/CaCO3)

Group Type EXPERIMENTAL

Toothpaste

Intervention Type DRUG

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

Interventions

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Toothpaste

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good general health
* Good oral health
Minimum Eligible Age

3 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Livia Maria Andaló Tenuta

Assistant Professor, Biochemistry and Cariology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Livia MA Tenuta, PhD

Role: STUDY_CHAIR

Piracicaba Dental School, University of Campinas

Locations

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Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 20662910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18042987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15798817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14691117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12740543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15914990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21180793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22163207 (View on PubMed)

Other Identifiers

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FOPBioq002

Identifier Type: -

Identifier Source: org_study_id