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This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.
The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.
One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA approved powered toothbrush (PTB)) will participate in the study.
For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group.
Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA accepted PTB and standard fluoride toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - ToothWave brush | Experimental | Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush. |
|
| Control - powered toothbrush | Sham Comparator | Subjects using a regular ADA-Accepted Powered Toothbrush, no RF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ToothWave | Device | RF-utilizing powered toothbrush for teeth whitening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extrinsic Stains | Extrinsic Stains will be evaluated using the validated Lobene Stain Index (LSI) Stain Intensity score range is between 0 and 3, where: 0 = no stain
The mean stain intensity will be calculated for both the gingival and body regions of the incisor teeth for each subject. Stain Area score rage is between 0 and 3, where: 0 = no stain
The mean stain area will be calculated for both the gingival and body regions of the incisor teeth for each subject. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tooth color assessment | VITA Bleachedguide 3D-Master shade guide, includes 29 shade levels defined by the American Dental Association (ADA). These shade levels represents the brightness of the tooth where 1 is the whitest and 29 is the darkest shade. | 6 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bennett T Amaechi, BDS, MS, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
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| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Double arm, single blind prospective study
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The Outcomes Assessors will not be exposed to the type of brush the subject is using or to the group they are assigned to (treatment or control).
| powered toothbrush | Device | regular powered toothbrush with no RF |
|