ToothWave Plaque and Gingivitis Study
| Status: | Recruiting |
|---|---|
| Conditions: | Dental, Nephrology |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/23/2019 |
| Start Date: | February 28, 2019 |
| End Date: | April 2019 |
| Contact: | Liora Levi, PhD |
| Email: | lioral@silkn.com |
| Phone: | +970-50-9260334 |
Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus
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.
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 effica-cy 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.
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.
Inclusion Criteria:
1. Adult subjects aged 18-70, that are in good health.
2. 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.
3. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
4. 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.
5. The subjects should be willing to comply with the study procedure and schedule,
including the follow up visits.
Exclusion Criteria:
1. Current or history of oral cavity cancer or oropharyngeal cancer.
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere
in the body.
3. Pregnant or nursing by subject report.
4. Any active condition in the oral cavity at the discretion of the investigator.
5. Any surgery in the oral cavity within 3 months prior to treatment, or before complete
healing.
6. Subjects that do not brush regularly.
7. Any condition that might make it unsafe for the subject to participate in this study,
at the discretion of the investigator.
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