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Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01589991
Enrollment
24
Registered
2012-05-02
Start date
2011-01-31
Completion date
2013-07-31
Last updated
2013-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Fluorosis

Keywords

toothpastes, bioavailability, sodium fluoride, monofluorphosphate, low-fluoride

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.

Interventions

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

Sponsors

University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
Yes

Inclusion criteria

* Good general health * Good oral health

Design outcomes

Primary

MeasureTime frameDescription
Fluoride concentration in biofilm fluid30minRemants 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 excretion8hUrine 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

MeasureTime frameDescription
Fluoride concentration in biofilm solid30minRemants 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 saliva30minNon-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 ingestedJanuary 2013 to July 2013Determination of amount of toothpaste ingested after one simulated brushing.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026