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

April 2, 2012 updated by: Livia Maria Andaló Tenuta, University of Campinas, Brazil
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Piracicaba, SP, Brazil, 13414903
        • Piracicaba Dental School, University of Campinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Gastric disorders
  • Renal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion
Time Frame: 3 hours
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.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration of fluoride in saliva after toothpaste ingestion
Time Frame: 3 hours
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.
3 hours
Urinary fluoride excretion (24-h) after toothpaste ingestion
Time Frame: 48 hours
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: Livia MA Tenuta, PhD, Piracicaba Dental School, University of Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 2, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOPFBioavailability2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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