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

NCT04092062 | Completed FDA Device

• 1 other identifier: D0116028A Texas
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

• 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 1. = light stain 2. = moderate stain 3. = 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 1. = stain covering up to one third of region 2. = stain covering up to two thirds of region 3. = 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 Outcomes (1)

• Tooth color assessment

  6 weeks

Study Arms (2)

Treatment - ToothWave brush

EXPERIMENTAL

Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.

Device: ToothWave

Control - powered toothbrush

SHAM COMPARATOR

Subjects using a regular ADA-Accepted Powered Toothbrush, no RF

Device: powered toothbrush

Interventions

ToothWave DEVICE

RF-utilizing powered toothbrush for teeth whitening

Also known as: RF toothbrush

Treatment - ToothWave brush

powered toothbrush DEVICE

regular powered toothbrush with no RF

Control - powered toothbrush

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Home Skinovations Ltd.: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bennett T Amaechi, BDS, MS, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcomes Assessors will not be exposed to the type of brush the subject is using or to the group they are assigned to (treatment or control).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double arm, single blind prospective study

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 17, 2019
• Study Start: August 7, 2019
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: December 11, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)