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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-04-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double arm, single blind prospective study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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Treatment - toothwave brush

Subjects using the Silk'n ToothWave RF utilizing toothbrush

Group Type EXPERIMENTAL

ToothWave

Intervention Type DEVICE

RF-utilizing powered toothbrush for teeth whitening

Control - powered toothbrush

Subject using a regular powered toothbrush with no RF.

Group Type SHAM_COMPARATOR

powered toothbrush

Intervention Type DEVICE

regular powered toothbrush with no RF

Interventions

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ToothWave

RF-utilizing powered toothbrush for teeth whitening

Intervention Type DEVICE

powered toothbrush

regular powered toothbrush with no RF

Intervention Type DEVICE

Other Intervention Names

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RF toothbrush

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes