NCT04596761

Brief Summary

The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

April 23, 2021

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

October 15, 2020

Last Update Submit

April 22, 2021

Conditions

GingivitisPlaqueCalculus, Dental

Outcome Measures

Primary Outcomes (1)

  • Calculus

    A significant calculus reduction in the treatment group as compared to the control group following 6 or 12 weeks of treatment.

    6-12 weeks

Secondary Outcomes (3)

  • reduction of calculus compared to baseline

    6-12 weeks

  • Oral health

    12 weeks

  • prevention of calculus accumulation

    6-12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush

Device: RF-utilizing powered toothbrush

Control group

EXPERIMENTAL

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, toothbrush with no RF

Control group

Eligibility Criteria

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

You may qualify if:

  • Adult subjects aged 18 years and older, that are in good health.
  • Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
  • 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 procedures and schedule, including the follow up visits.
  • Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.

You may not qualify if:

  • Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
  • Regular users of a chlorhexidine mouthrinse.
  • Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
  • 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.
  • 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

  • Jeffery L Milleman, DDS, MPA

    Salus Research

    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: Single blind prospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

July 15, 2020

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

April 23, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)