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OpenTrials
Completed

NCT Number: NCT01094210

Evaluation of a Low-fluoride Anticaries Toothpaste

The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.

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Key information

Conditions

Tooth Abnormality Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Diagnostic Clinic within the University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 30 adult subjects (between 18-50 years of age)

Treatment and study plan

Fluorides, Topical

Drug

500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.

Primary outcomes

  1. Surface Microhardness

    Time frame: 30 days

    Strength measurements made at the enamel surface of the enamel specimen

  2. Transverse Microradiography

    Time frame: 30 days

    X-ray analysis of enamel lesion

  3. Cross-Sectional Microhardness

    Time frame: 30 days

    Strength measurements made within the enamel lesion of the enamel specimen

Sponsors and collaborators

Lead sponsor

Indiana Nanotech, LLC

Other

Collaborators

  • The University of Texas Health Science Center at San Antonio

Registry information

Official study title

Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2010
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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