NCT03885609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

September 10, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

March 20, 2019

Last Update Submit

September 9, 2019

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

  • Extrinsic Stains

    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.

    6 weeks

Secondary Outcomes (1)

  • Tooth color assessment

    6 weeks

Study Arms (2)

Treatment - toothwave brush

EXPERIMENTAL

Subjects using the Silk'n ToothWave RF utilizing toothbrush

Device: ToothWave

Control - powered toothbrush

SHAM COMPARATOR

Subject using a regular powered toothbrush with no RF.

Device: powered toothbrush

Interventions

ToothWaveDEVICE

RF-utilizing powered toothbrush for teeth whitening

Also known as: RF toothbrush
Treatment - toothwave brush
powered toothbrushDEVICE

regular powered toothbrush with no RF

Control - powered toothbrush

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salus research

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

  • 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.

    PMID: 34973707DERIVED

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Jeffery L Milleman, DDS, MPA

    Salus research center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double arm, single blind prospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 21, 2019

Study Start

February 28, 2019

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

September 10, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)