Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Livia Maria Andaló Tenuta, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01571050
First received: March 30, 2012
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

The risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. Currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. However, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. Since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.


Condition Intervention Phase
Dental Fluorosis
Drug: Purified water
Drug: Fresh MFP/CaCO3 toothpaste
Drug: Fresh NaF/SiO2 toothpaste
Drug: Aged NaF/SiO2 toothpaste
Drug: Aged MFP/CaCO3 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Saliva will be collected before and up to 3 hours after ingestion of the toothpastes or negative control. Collections (during 3 min) will be made at 0 (immediately before ingestion), 15, 30, 45, 60, 120 and 180 min after ingestion.


Secondary Outcome Measures:
  • Maximum concentration of fluoride in saliva after toothpaste ingestion [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Saliva collected up to 3 hours after the ingestion of toothpastes or negative control will be analyzed for fluoride concentration and the maximum concentration during this period will be recorded.

  • Urinary fluoride excretion (24-h) after toothpaste ingestion [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Urine will be collected for the 24 hours preceeding the ingestion of the toothpastes or negative control and for the 24 hours after the ingestion. The difference in the amount of fluoride excreted in 24h urine samples, after or before the treatments, will be calculated.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresh NaF/SiO2 toothpaste Drug: Fresh NaF/SiO2 toothpaste
Ingestion of 49.5 mg of a fresh toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.
Placebo Comparator: Purified water Drug: Purified water
Ingestion of 30 mL of purified water
Experimental: Aged NaF/SiO2 toothpaste Drug: Aged NaF/SiO2 toothpaste
Ingestion of 49.5 mg of a toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.
Experimental: Fresh MFP/CaCO3 toothpaste Drug: Fresh MFP/CaCO3 toothpaste
Ingestion of 31.9 mg of a fresh toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.
Experimental: Aged MFP/CaCO3 toothpaste Drug: Aged MFP/CaCO3 toothpaste
Ingestion of 31.9 mg of a toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health
  • Good oral health
  • Normal salivary flow rate

Exclusion Criteria:

  • Gastric disorders
  • Renal disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571050

Locations
Brazil
Piracicaba Dental School, University of Campinas
Piracicaba, SP, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Livia MA Tenuta, PhD Piracicaba Dental School, University of Campinas
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Livia Maria Andaló Tenuta, Assistant Professor, Biochemistry and Cariology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01571050     History of Changes
Other Study ID Numbers: FOPFBioavailability2011
Study First Received: March 30, 2012
Last Updated: April 2, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Campinas, Brazil:
toothpastes
dental fluorosis
fluoride
bioavailability

Additional relevant MeSH terms:
Fluoride Poisoning
Fluorosis, Dental
Poisoning
Substance-Related Disorders
Tooth Diseases
Stomatognathic Diseases
Calcium Carbonate
Fluorides
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014