Back to resultsSafety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
Primary Purpose
Tooth Discoloration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ToothWave
powered toothbrush
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Discoloration
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment - ToothWave brush
Control - powered toothbrush
Arm Description
Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.
Subjects using a regular ADA-Accepted Powered Toothbrush, no RF
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04092062
First Posted
September 15, 2019
Last Updated
December 10, 2020
Sponsor
Home Skinovations Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04092062
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
January 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Home Skinovations Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double arm, single blind prospective study
Masking
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).
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment - ToothWave brush
Arm Type
Experimental
Arm Description
Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.
Arm Title
Control - powered toothbrush
Arm Type
Sham Comparator
Arm Description
Subjects using a regular ADA-Accepted Powered Toothbrush, no RF
Intervention Type
Device
Intervention Name(s)
ToothWave
Other Intervention Name(s)
RF toothbrush
Intervention Description
RF-utilizing powered toothbrush for teeth whitening
Intervention Type
Device
Intervention Name(s)
powered toothbrush
Intervention Description
regular powered toothbrush with no RF
Primary Outcome Measure Information:
Title
Extrinsic Stains
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Tooth color assessment
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS, MS, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
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