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

• ClinicalTrials.gov Identifier: NCT03885609
• Recruitment Status: Completed
• First Posted: March 21, 2019
• Last Update Posted: September 10, 2019
• Sponsor: Home Skinovations Ltd.
• Information provided by (Responsible Party): Home Skinovations Ltd.

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 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 Power Toothbrush for Extrinsic Stain Reduction
• Actual Study Start Date: February 28, 2019
• Actual Primary Completion Date: April 12, 2019
• Actual Study Completion Date: April 12, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment - toothwave brush; Subjects using the Silk'n ToothWave RF utilizing toothbrush	Device: ToothWave; RF-utilizing powered toothbrush for teeth whitening; Other Name: RF toothbrush
Sham Comparator: Control - powered toothbrush; Subject using a regular powered toothbrush with no RF.	Device: powered toothbrush; regular powered toothbrush with no RF

Outcome Measures

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.

Eligibility Criteria

• 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 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.

Contacts and Locations

Locations

United States, Indiana

Salus research

Fort Wayne, Indiana, United States, 46825

Sponsors and Collaborators

Home Skinovations Ltd.

Investigators

• Principal Investigator: Jeffery L Milleman, DDS, MPA; Salus research center

More Information

• Responsible Party: Home Skinovations Ltd.
• ClinicalTrials.gov Identifier: NCT03885609
• Other Study ID Numbers: DO116028A
• First Posted: March 21, 2019
• Last Update Posted: September 10, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Tooth Discoloration; Tooth Diseases; Stomatognathic Diseases