Calculus, Dental, Gingivitis, Plaque
Conditions
Brief summary
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
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.
Interventions
RF-utilizing Powered toothbrush
Placebo control, toothbrush with no RF
Sponsors
Home Skinovations Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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).
Intervention model description
Single blind prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult subjects aged 18-70, that are in good health. 2. 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculus | 12 weeks | A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental plaque | 6 weeks | A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy. |
| Gingival inflammation | 6 weeks | A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI). |
Countries
United States
Outcome results
None listed