Status:
COMPLETED
Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
Lead Sponsor:
Home Skinovations Ltd.
Conditions:
Tooth Discoloration
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.
Detailed Description
The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks. One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adult subjects aged 18-70, that are in good health.
- Subjects should have notable extrinsic dental stains on the 6 maxillary labial front teeth, or on the 6 mandibular front teeth (lingual or labial), with a total extrinsic tooth stain score ≥14 according to the LSI.
- Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 as assessed by the Investigator.
- Subject front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachedguide 3D-Master or the Vita EasyShade device.
- 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, and will refrain from using any other teeth whitening technologies during this period.
- The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.
- Exclusion Criteria
- 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 treated area 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 the study, at the discretion of the investigator.
Exclusion
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2020
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04092062
Start Date
August 7 2019
End Date
January 28 2020
Last Update
December 11 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