Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

October 25, 2013 updated by: Livia Maria Andaló Tenuta, University of Campinas, Brazil
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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
    • Sao Paulo
      • Piracicaba, Sao Paulo, 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

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good general health
  • Good oral health

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoride concentration in biofilm fluid
Time Frame: 30min
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.
30min
Urinary fluoride excretion
Time Frame: 8h
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).
8h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoride concentration in biofilm solid
Time Frame: 30min
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.
30min
Fluoride concentration in saliva
Time Frame: 30min
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.
30min
Amount of toothpaste ingested
Time Frame: January 2013 to July 2013
Determination of amount of toothpaste ingested after one simulated brushing.
January 2013 to July 2013

Collaborators and Investigators

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

Sponsor

University of Campinas, Brazil

Investigators

  • Study Chair: 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)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOPBioq002

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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