Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)

Tooth Discoloration Clinical Trial

Official title:

Safety and Efficacy of the ToothWave (Model H7001) Powered Toothbrush Home Use Device for Extrinsic Stain Reduction (Texas)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092062
• Other study ID #: D0116028A Texas
• Status: Completed
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: January 28, 2020

Study information

• Verified date: September 2019
• Source: Home Skinovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Device:
• ToothWave
RF-utilizing powered toothbrush for teeth whitening
• powered toothbrush
regular powered toothbrush with no RF

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Home Skinovations Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extrinsic Stains	Extrinsic Stains will be evaluated using the validated Lobene Stain Index (LSI); Stain Intensity score range is between 0 and 3, where: 0 = no stain; = light stain; = moderate stain; = heavy stain; The mean stain intensity will be calculated for both the gingival and body regions of the incisor teeth for each subject.; Stain Area score rage is between 0 and 3, where: 0 = no stain; = stain covering up to one third of region; = stain covering up to two thirds of region; = stain covering more than two thirds of region; The mean stain area will be calculated for both the gingival and body regions of the incisor teeth for each subject.	6 weeks
Secondary	Tooth color assessment	VITA Bleachedguide 3D-Master shade guide, includes 29 shade levels defined by the American Dental Association (ADA). These shade levels represents the brightness of the tooth where 1 is the whitest and 29 is the darkest shade.	6 weeks