Tooth Abnormality Clinical Trial
Official title:
Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology
| Verified date | June 2011 |
| Source | Indiana Nanotech, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | March 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - 30 adult subjects (between 18-50 years of age) |
Observational Model: Case-Crossover, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Dental Diagnostic Clinic within the University of Texas Health Science Center | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Indiana Nanotech, LLC | The University of Texas Health Science Center at San Antonio |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Surface Microhardness | Strength measurements made at the enamel surface of the enamel specimen | 30 days | No |
| Primary | Transverse Microradiography | X-ray analysis of enamel lesion | 30 days | No |
| Primary | Cross-Sectional Microhardness | Strength measurements made within the enamel lesion of the enamel specimen | 30 days | No |