Back to resultsToothWave Plaque and Gingivitis 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
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
Inclusion Criteria:
- Adult subjects aged 18-70, that are in good health.
Subject must have:
2.2. 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.
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.
Sites / Locations
- Salus research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with RF-utilizing powered toothbrush
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Outcomes
Primary Outcome Measures
Dental plaque
A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).
Gingival inflammation
A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).
Secondary Outcome Measures
Calculus
A reduction of calculus deposits as evaluated by Volpe-Manhold Index
Full Information
NCT ID
NCT03885323
First Posted
February 12, 2019
Last Updated
November 23, 2020
Sponsor
Home Skinovations Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03885323
Brief Title
ToothWave Plaque and Gingivitis Study
Official Title
Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (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 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 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. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, 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
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
86 (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 RF-utilizing powered toothbrush
Arm Title
Control group
Arm Type
Placebo 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, with no RF
Primary Outcome Measure Information:
Title
Dental plaque
Description
A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).
Time Frame
6 weeks
Title
Gingival inflammation
Description
A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Calculus
Description
A reduction of calculus deposits as evaluated by Volpe-Manhold Index
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:
2.2. 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.
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
Jeffry L. Milleman, DDS, MPA
Organizational Affiliation
Salus Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ToothWave Plaque and Gingivitis Study
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