Clinical trial NCT03885609: Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
Official title: Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Lead sponsor: Home Skinovations Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double arm, single blind prospective study
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Extrinsic Stains
timeFrame: 6 weeks
Secondary outcomes:
measure: Tooth color assessment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus research
state: Indiana
Study officials:
affiliation: Salus research center
name: Jeffery L Milleman, DDS, MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amaechi BT, Levi L, Silman Z, Evans V, Shehata MAS, Alonso-Ryan JR, Phillips TS, Ugwokaegbe PC, Farokhi MR. Clinical efficacy of a novel radiofrequency toothbrush for tooth stain reduction and tooth whitening: A randomized controlled trial. J Am Dent Assoc. 2022 Apr;153(4):342-353. doi: 10.1016/j.adaj.2021.09.006. Epub 2021 Dec 29.