Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double arm, single blind prospective study
Primary Purpose
Treatment
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).

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229-3900
Contact:
Bennett T Amaechi, BDS, MS, PhD
210-567-3185
amaechi@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Home Skinovations Ltd.

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.