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The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.
This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.
The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.
One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.
For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The treatment is conducted with the ToothWave toothbrush Intervention: brushing with RF-utilizing powered toothbrush |
|
| Control group | Placebo Comparator | Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF utilizing powered toothbrush | Device | RF utilizing Powered toothbrush |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dental plaque | A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI). | 6 weeks |
| Gingival inflammation | A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Calculus | A reduction of calculus deposits as evaluated by Volpe-Manhold Index | 6 weeks |
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Inclusion Criteria:
Adult subjects aged 18-70, that are in good health.
Subject must have:
2.2. Baseline gingivitis (MGI) score of at least 1.80, 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI Index. 2.4. Total Calculus deposits greater than 7 according to the Volpe-Manhold Index.
Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffry L. Milleman, DDS, MPA | Salus Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus research | Fort Wayne | Indiana | 46825 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| D003728 | Dental Calculus |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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Single blind prospective study
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Participants will not know if the toothbrush is a treatment or control brush. Outcome assessor will be blinded as well and will not know which product was dispensed to which participant.
| Control placebo with no RF | Device | Placebo control, with no RF |
|
| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D002137 | Calculi |