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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092062
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Home Skinovations Ltd.

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.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Device: ToothWave Device: powered toothbrush Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double arm, single blind prospective study
Masking: Single (Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the ToothWave (Model H7001) Powered Toothbrush Home Use Device for Extrinsic Stain Reduction (Texas)
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: Treatment - ToothWave brush
Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.
Device: ToothWave
RF-utilizing powered toothbrush for teeth whitening
Other Name: RF toothbrush

Sham Comparator: Control - powered toothbrush
Subjects using a regular ADA-Accepted Powered Toothbrush, no RF
Device: powered toothbrush
regular powered toothbrush with no RF




Primary Outcome Measures :
  1. Extrinsic Stains [ Time Frame: 6 weeks ]

    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.



Secondary Outcome Measures :
  1. Tooth color assessment [ Time Frame: 6 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092062


Contacts
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Contact: Liora Levi, PhD +970-50-9260334 lioral@silkn.com

Locations
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United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Bennett T Amaechi, BDS, MS, PhD    210-567-3185    amaechi@uthscsa.edu   
Sponsors and Collaborators
Home Skinovations Ltd.
Investigators
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Principal Investigator: Bennett T Amaechi, BDS, MS, PhD The University of Texas Health Science Center at San Antonio
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Responsible Party: Home Skinovations Ltd.
ClinicalTrials.gov Identifier: NCT04092062    
Other Study ID Numbers: D0116028A Texas
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases