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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 a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 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. Calculus condition will be measured after 12 weeks in addition to the other timepoints. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, 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 Radio frequency (RF)-utilizing powered toothbrush |
|
| Control group | Sham 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 |
|---|---|---|
| Calculus | A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dental plaque | A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy. | 6 weeks |
| Gingival inflammation | A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI). |
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Inclusion Criteria
Adult subjects aged 18-70, that are in good health.
Subject must have:
2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).
2.4. Total Calculus deposits greater than 9 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 |
|---|---|---|
| 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 |
|---|---|
| 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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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).
| Control placebo with no RF | Device | Placebo control, toothbrush with no RF |
|
| 6 weeks |
| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D002137 | Calculi |