Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.

Conditions
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Gingivitis, Plaque, Calculus, Dental

Intervention / Treatment
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* Device: RF-utilizing powered toothbrush
* Device: Control placebo with no RF


Participation Criteria
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Eligibility Criteria
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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 Current or history of oral cavity cancer or oropharyngeal cancer. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. Pregnant or nursing by subject report. Any active condition in the oral cavity at the discretion of the investigator. Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing. Subjects that do not brush regularly. Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind prospective study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush | Device: RF-utilizing powered toothbrush<br>* RF-utilizing Powered toothbrush<br>* Other names: RF toothbrush;|
| Sham Comparator: Control group<br>Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF | Device: Control placebo with no RF<br>* Placebo control, toothbrush with no RF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculus | A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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). | 6 weeks |