NCT03885323

Brief Summary

The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

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

First Submitted

Initial submission to the registry

February 12, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

November 25, 2020

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

February 12, 2019

Last Update Submit

November 23, 2020

Conditions

GingivitisPlaqueCalculus, Dental

Outcome Measures

Primary Outcomes (2)

  • Dental plaque

    A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).

    6 weeks

  • Gingival inflammation

    A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).

    6 weeks

Secondary Outcomes (1)

  • Calculus

    6 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment is conducted with the ToothWave toothbrush Intervention: brushing with RF-utilizing powered toothbrush

Device: RF utilizing powered toothbrush

Control group

PLACEBO COMPARATOR

Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF

Device: Control placebo with no RF

Interventions

RF utilizing powered toothbrushDEVICE

RF utilizing Powered toothbrush

Also known as: RF toothbrush
Treatment group
Control placebo with no RFDEVICE

Placebo control, with no RF

Control group

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.
  • Subject must have:
  • Baseline gingivitis (MGI) score of at least 1.80, 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI Index. 2.4. Total Calculus deposits greater than 7 according to the Volpe-Manhold Index.
  • Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
  • 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, including the follow up visits.

You may not qualify if:

  • Current or history of oral cavity cancer or oropharyngeal cancer.
  • 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 oral cavity within 3 months prior to treatment, or before complete healing.
  • Subjects that do not brush regularly.
  • Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salus research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

GingivitisPlaque, AmyloidDental Calculus

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDental DepositsTooth DiseasesCalculi

Study Officials

  • Jeffry L. Milleman, DDS, MPA

    Salus Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not know if the toothbrush is a treatment or control brush. Outcome assessor will be blinded as well and will not know which product was dispensed to which participant.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single blind prospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 21, 2019

Study Start

February 28, 2019

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

November 25, 2020

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)