Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
NCT ID: NCT04092062
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2019-08-07
2020-01-28
Brief Summary
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Detailed Description
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One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA approved powered toothbrush (PTB)) will participate in the study.
For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group.
Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA accepted PTB and standard fluoride toothpaste.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment - ToothWave brush
Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.
ToothWave
RF-utilizing powered toothbrush for teeth whitening
Control - powered toothbrush
Subjects using a regular ADA-Accepted Powered Toothbrush, no RF
powered toothbrush
regular powered toothbrush with no RF
Interventions
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ToothWave
RF-utilizing powered toothbrush for teeth whitening
powered toothbrush
regular powered toothbrush with no RF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 as assessed by the Investigator.
4. 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.
5. 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.
6. 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.
7. 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
2. Pregnant or nursing by subject report.
3. Any active condition in the oral cavity at the discretion of the investigator.
4. Any surgery in the treated area within 3 months prior to treatment, or before complete healing.
5. Subjects that do not brush regularly.
6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
18 Years
70 Years
ALL
Yes
Sponsors
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Home Skinovations Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Bennett T Amaechi, BDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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D0116028A Texas
Identifier Type: -
Identifier Source: org_study_id