Clinical trial NCT04092062: Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
Official title: Safety and Efficacy of the ToothWave (Model H7001) Powered Toothbrush Home Use Device for Extrinsic Stain Reduction (Texas)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Lead sponsor: Home Skinovations Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double arm, single blind prospective study
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria

1. Adult subjects aged 18-70, that are in good health.
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

1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
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.

Primary outcomes:
measure: Extrinsic Stains
timeFrame: 6 weeks
Secondary outcomes:
measure: Tooth color assessment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Bennett T Amaechi, BDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: