Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Sponsors

Lead Sponsor: University of Campinas, Brazil

Source University of Campinas, Brazil
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.

Overall Status Completed
Start Date January 2011
Completion Date July 2013
Primary Completion Date December 2012
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Fluoride concentration in biofilm fluid 30min
Urinary fluoride excretion 8h
Secondary Outcome
Measure Time Frame
Fluoride concentration in biofilm solid 30min
Fluoride concentration in saliva 30min
Amount of toothpaste ingested January 2013 to July 2013
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: Toothpaste

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

Eligibility

Criteria:

Inclusion Criteria:

- Good general health

- Good oral health

Gender: All

Minimum Age: 3 Years

Maximum Age: 4 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Livia MA Tenuta, PhD Study Chair Piracicaba Dental School, University of Campinas
Location
Facility: Piracicaba Dental School, University of Campinas
Location Countries

Brazil

Verification Date

October 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Campinas, Brazil

Investigator Full Name: Livia Maria Andaló Tenuta

Investigator Title: Assistant Professor, Biochemistry and Cariology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Non-fluoride toothpaste

Type: Placebo Comparator

Label: Toothpaste 550 µg F/g (NaF/SiO2)

Type: Experimental

Label: Toothpaste 1100 µg F/g (NaF/SiO2)

Type: Experimental

Label: Toothpaste 1450 µg F/g (MFP/CaCO3)

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Prevention

Masking: Single (Investigator)

Source: ClinicalTrials.gov