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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 90 participants
Intervention Model: Parallel Assignment
Intervention Model Description:Single-blind prospective study
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).
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.
Actual Study Start Date: August 7, 2019
Estimated Primary Completion Date: May 31, 2020
Estimated Study Completion Date: May 31, 2020
Primary Outcome Measures :
- Calculus [ Time Frame: 12 weeks ]
A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.
Secondary Outcome Measures :
- Dental plaque [ Time Frame: 6 weeks ]
A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.
- Gingival inflammation [ Time Frame: 6 weeks ]
A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).
Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
- 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.
- 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.