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Evaluation of a Low-fluoride Anticaries Toothpaste

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
Indiana Nanotech, LLC
ClinicalTrials.gov Identifier:
NCT01094210
First received: March 25, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Tooth Abnormality
 Drug: Fluorides, Topical

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana Nanotech, LLC:

Estimated Enrollment: 30
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094210

Locations
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
University of Texas
  More Information

No publications provided

Responsible Party: Dr. Bennett T. Amaechi, Associate Professor and Director of Cariology, University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01094210     History of Changes
Other Study ID Numbers: 1R43DE020998-01
Study First Received: March 25, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Nanotech, LLC:
Anti-erosion dental benefits

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

ClinicalTrials.gov processed this record on May 21, 2013