Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains) Over 8 Weeks of Unsupervised Use.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whitening Toothpaste | Experimental |
| |
| Non-Whitening Toothpaste | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste | Other | Toothpaste with stain removing abilities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tooth color | The Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces will be used for measurment of tooth color. The Primary Endpoint is the MLSI (extrinsic stain mean scores) at the 8-week timepoint compared to baseline. The between treatments would also be a primary endpoint after 8 weeks of unsupervised use. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Whitening | To determine the improvement in tooth shade as measured by Classic Vita Shade Guide after 8 weeks of use of the two dentifrices as compared to their respective baseline shades. The Secondary Endpoint is the L*a*b* comparison after 8 weeks of use, both within and between treatment groups. Classic Vita Shade Guide. | 8 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffery L Milleman, DDS, MPA | Salus Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided