Evaluation of a Low-fluoride Anticaries Toothpaste
Completed
- Conditions
- Tooth Abnormality
- Interventions
- Drug: Fluorides, Topical
- Registration Number
- NCT01094210
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 30 adult subjects (between 18-50 years of age)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description G1 Fluorides, Topical 500 ppm F Test Toothpaste G2 Fluorides, Topical 1100 ppm F Control Toothpaste
- Primary Outcome Measures
Name Time Method Transverse Microradiography 30 days X-ray analysis of enamel lesion
Surface Microhardness 30 days Strength measurements made at the enamel surface of the enamel specimen
Cross-Sectional Microhardness 30 days Strength measurements made within the enamel lesion of the enamel specimen
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dental Diagnostic Clinic within the University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States