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Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ToothWave
powered toothbrush
Sponsored by
Home Skinovations Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult subjects aged 18-70, that are in good health.
  2. Subjects should have notable extrinsic dental stains on the front teeth with a total extrin-sic facial tooth stain score ≥14 according to the LSI.
  3. 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.
  4. The subjects should be willing to comply with the study procedure and schedule, includ-ing the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
  5. The subject did not perform any procedure for teeth whitening (either at home or in clin-ic) at least 3 years prior to participating in the study

Exclusion Criteria:

  1. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator
  2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
  3. Pregnant or nursing by subject report.
  4. Any active condition in the oral cavity at the discretion of the investigator.
  5. Any surgery in the treated area within 3 months prior to treatment, or before complete healing.
  6. Subjects that do not brush regularly.
  7. Regular tobacco smokers.

Sites / Locations

  • Salus research

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 RF utilizing toothbrush

Subject using a regular powered toothbrush with 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

First Posted
March 20, 2019
Last Updated
September 9, 2019
Sponsor
Home Skinovations Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03885609
Brief Title
Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
Official Title
Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
April 12, 2019 (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 Power Toothbrush for stains reduction and improvement of teeth shade.
Detailed Description
The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks. One treatment group (Silk'n power toothbrush - ToothWave) and 1 control group (an ADA approved power 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 manufactur-er'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 ac-cepted PTB and the same 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
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment - toothwave brush
Arm Type
Experimental
Arm Description
Subjects using the Silk'n ToothWave RF utilizing toothbrush
Arm Title
Control - powered toothbrush
Arm Type
Sham Comparator
Arm Description
Subject using a regular powered toothbrush with 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 front teeth with a total extrin-sic facial tooth stain score ≥14 according to the LSI. 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, includ-ing 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 clin-ic) at least 3 years prior to participating in the study Exclusion Criteria: Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator 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. Regular tobacco smokers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery L Milleman, DDS, MPA
Organizational Affiliation
Salus research center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34973707
Citation
Amaechi BT, Levi L, Silman Z, Evans V, Shehata MAS, Alonso-Ryan JR, Phillips TS, Ugwokaegbe PC, Farokhi MR. Clinical efficacy of a novel radiofrequency toothbrush for tooth stain reduction and tooth whitening: A randomized controlled trial. J Am Dent Assoc. 2022 Apr;153(4):342-353. doi: 10.1016/j.adaj.2021.09.006. Epub 2021 Dec 29.
Results Reference
derived

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Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction

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