Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Livia Maria Andaló Tenuta, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01589991
First received: April 30, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Dental Caries
Dental Fluorosis
Drug: Toothpaste
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Fluoride concentration in biofilm fluid [ Time Frame: 30min ] [ Designated as safety issue: No ]
    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.

  • Urinary fluoride excretion [ Time Frame: 8h ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Fluoride concentration in biofilm solid [ Time Frame: 30min ] [ Designated as safety issue: No ]
    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.

  • Fluoride concentration in saliva [ Time Frame: 30min ] [ Designated as safety issue: No ]
    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.

  • Amount of toothpaste ingested [ Time Frame: January 2013 to July 2013 ] [ Designated as safety issue: No ]
    Determination of amount of toothpaste ingested after one simulated brushing.


Enrollment: 24
Study Start Date: January 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Non-fluoride toothpaste Drug: Toothpaste
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Experimental: Toothpaste 550 µg F/g (NaF/SiO2) Drug: Toothpaste
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Experimental: Toothpaste 1100 µg F/g (NaF/SiO2) Drug: Toothpaste
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Experimental: Toothpaste 1450 µg F/g (MFP/CaCO3) Drug: Toothpaste
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health
  • Good oral health
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01589991

Locations
Brazil
Piracicaba Dental School, University of Campinas
Piracicaba, Sao Paulo, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Study Chair: Livia MA Tenuta, PhD Piracicaba Dental School, University of Campinas
  More Information

Additional Information:
Publications:

Responsible Party: Livia Maria Andaló Tenuta, Assistant Professor, Biochemistry and Cariology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01589991     History of Changes
Other Study ID Numbers: FOPBioq002
Study First Received: April 30, 2012
Last Updated: October 25, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Campinas, Brazil:
toothpastes
bioavailability
sodium fluoride
monofluorphosphate
low-fluoride

Additional relevant MeSH terms:
Dental Caries
Fluoride Poisoning
Fluorosis, Dental
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Poisoning
Chemically-Induced Disorders
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014