Status:
COMPLETED
Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
Lead Sponsor:
Home Skinovations Ltd.
Conditions:
Gingivitis
Plaque
Eligibility:
All Genders
18-70 years
Phase:
NA
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,...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adult subjects aged 18-70, that are in good health.
- Subject must have:
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04092075
Start Date
August 7 2019
End Date
April 30 2020
Last Update
July 29 2020
Active Locations (1)
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1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900