Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Loma Linda University | OTHER |
Not provided
Not provided
Not provided
Not provided
The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.
A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Toothbrush 1 | Active Comparator | 1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. |
|
| Experimental Toothbrush 2 | Active Comparator | 2. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric Toothbrush | Device | Electric Toothbrush used to remove dental plaque and resolve gingivitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in mean dental plaque | Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject. | 3 and 6 weeks of product use |
| change in mean gingivitis | gingivitis measurement is served as secondary efficacy variable | 3 and 6 weeks of product use |
Not provided
Not provided
Inclusion Criteria:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yiming Yi, DDS/PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
Parallel Assignment
Not provided
Not provided
Product Code: XX Brush twice daily (morning and evening) for at least 2 minutes each time Cover the entire length of bristles with toothpaste
| oral health care application | Other | phone application that shows the user brushing efficiency real time |
|
| D009057 |
| Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |