search
Back to results

Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

Primary Purpose

Gingivitis, Plaque, Calculus, Dental

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RF-utilizing powered toothbrush
Control placebo with no RF
Sponsored by
Home Skinovations Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. Adult subjects aged 18-70, that are in good health.

  2. Subject must have:

    2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).

    2.4. Total Calculus deposits greater than 9 according to the Volpe-Manhold Index.

  3. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
  4. 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.
  5. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.

Exclusion Criteria

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Calculus
A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.

Secondary Outcome Measures

Dental plaque
A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.
Gingival inflammation
A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).

Full Information

First Posted
September 15, 2019
Last Updated
July 27, 2020
Sponsor
Home Skinovations Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04092075
Brief Title
Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
Official Title
Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Home Skinovations Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus. The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks. One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study. For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. The average data sets will be calculated for each group. Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque, Calculus, Dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind prospective study
Masking
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Intervention Type
Device
Intervention Name(s)
RF-utilizing powered toothbrush
Other Intervention Name(s)
RF toothbrush
Intervention Description
RF-utilizing Powered toothbrush
Intervention Type
Device
Intervention Name(s)
Control placebo with no RF
Intervention Description
Placebo control, toothbrush with no RF
Primary Outcome Measure Information:
Title
Calculus
Description
A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Dental plaque
Description
A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.
Time Frame
6 weeks
Title
Gingival inflammation
Description
A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Adult subjects aged 18-70, that are in good health. Subject must have: 2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index). 2.4. Total Calculus deposits greater than 9 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS, MS, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

We'll reach out to this number within 24 hrs