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

Home Skinovations

Status: Completed

Conditions: Tooth Discoloration

Treatments: Device: ToothWave; Device: powered toothbrush

Study type: Interventional

Funder types: Industry

Identifiers

NCT03885609

DO116028A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Treatment - toothwave brush

Experimental group

Description:

Subjects using the Silk'n ToothWave RF utilizing toothbrush

Treatment:

Device: ToothWave

Control - powered toothbrush

Sham Comparator group

Description:

Subject using a regular powered toothbrush with no RF.

Treatment:

Device: powered toothbrush