Evaluation of a Low-fluoride Anticaries Toothpaste

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Abnormality
• Intervention / Treatment: Drug: Fluorides, Topical

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Dental Diagnostic Clinic within the University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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,

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface Microhardness	Strength measurements made at the enamel surface of the enamel specimen	30 days
Transverse Microradiography	X-ray analysis of enamel lesion	30 days
Cross-Sectional Microhardness	Strength measurements made within the enamel lesion of the enamel specimen	30 days

Collaborators and Investigators

• Sponsor: Indiana Nanotech, LLC
• Collaborators: The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Anti-erosion dental benefits
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: 1R43DE020998-01 (U.S. NIH Grant/Contract)