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This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Power Toothbrush for stains reduction and improvement of teeth shade.
The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.
One treatment group (Silk'n power toothbrush - ToothWave) and 1 control group (an ADA approved power 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 manufactur-er'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 ac-cepted PTB and the same standard fluoride toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - toothwave brush | Experimental | Subjects using the Silk'n ToothWave RF utilizing toothbrush |
|
| Control - powered toothbrush | Sham Comparator | Subject using a regular powered toothbrush with 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 |
|---|---|---|
| Jeffery L Milleman, DDS, MPA | Salus research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus research | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34973707 | Derived | Amaechi BT, Levi L, Silman Z, Evans V, Shehata MAS, Alonso-Ryan JR, Phillips TS, Ugwokaegbe PC, Farokhi MR. Clinical efficacy of a novel radiofrequency toothbrush for tooth stain reduction and tooth whitening: A randomized controlled trial. J Am Dent Assoc. 2022 Apr;153(4):342-353. doi: 10.1016/j.adaj.2021.09.006. Epub 2021 Dec 29. |
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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 |
|