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Evaluation of a Low-fluoride Anticaries Toothpaste

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ClinicalTrials.gov Identifier: NCT01094210
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Dr. Robert L. Karlinsey, Indiana Nanotech, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Tooth Abnormality Drug: Fluorides, Topical

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology
Study Start Date : September 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
G1
500 ppm F Test Toothpaste
Drug: Fluorides, Topical
500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.

G2
1100 ppm F Control Toothpaste
Drug: Fluorides, Topical
500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This in situ study will recruit 30 adult subjects (between 18-50 years of age). No potential subject will be excluded from this study, regardless of their gender or racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in the trial will be women. This distribution will allow for meaningful comparisons between gender groups. We will recruit patients attending the clinics of UTHSCSA dental school clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus, minorities will be included at a similar rate to that in the general population attending for dental care,
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094210


Locations
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United States, Texas
Dental Diagnostic Clinic within the University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Indiana Nanotech, LLC
The University of Texas Health Science Center at San Antonio

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Responsible Party: Dr. Robert L. Karlinsey, Managing Member, Indiana Nanotech, LLC
ClinicalTrials.gov Identifier: NCT01094210     History of Changes
Other Study ID Numbers: 1R43DE020998-01 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: June 2011

Keywords provided by Dr. Robert L. Karlinsey, Indiana Nanotech, LLC:
Anti-erosion dental benefits

Additional relevant MeSH terms:
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Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs