Evaluation of a Low-fluoride Anticaries Toothpaste

NCT ID: NCT01094210

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Abnormality

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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G1

500 ppm F Test Toothpaste

Fluorides, Topical

Intervention Type DRUG

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

G2

1100 ppm F Control Toothpaste

Fluorides, Topical

Intervention Type DRUG

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

Interventions

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Fluorides, Topical

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 30 adult subjects (between 18-50 years of age)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

Indiana Nanotech, LLC

OTHER

Sponsor Role lead

Responsible Party

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Dr. Robert L. Karlinsey

Managing Member

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dental Diagnostic Clinic within the University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1R43DE020998-01

Identifier Type: NIH

Identifier Source: org_study_id

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