Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
- Conditions
- Tooth Discoloration
- Interventions
- Device: powered toothbrushDevice: ToothWave
- Registration Number
- NCT03885609
- Lead Sponsor
- Home Skinovations Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control - powered toothbrush powered toothbrush Subject using a regular powered toothbrush with no RF. Treatment - toothwave brush ToothWave Subjects using the Silk'n ToothWave RF utilizing toothbrush
- Primary Outcome Measures
Name Time Method Extrinsic Stains 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
Name Time Method Tooth color assessment 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.
Trial Locations
- Locations (1)
Salus research
🇺🇸Fort Wayne, Indiana, United States