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ToothWave Plaque and Gingivitis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885323
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Home Skinovations Ltd.

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date November 25, 2020
Actual Study Start Date  ICMJE February 28, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Dental plaque [ Time Frame: 6 weeks ]
    A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).
  • Gingival inflammation [ Time Frame: 6 weeks ]
    A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
Calculus [ Time Frame: 6 weeks ]
A reduction of calculus deposits as evaluated by Volpe-Manhold Index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ToothWave Plaque and Gingivitis Study
Official Title  ICMJE Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single blind prospective study
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Gingivitis
  • Plaque
  • Calculus, Dental
Intervention  ICMJE
  • Device: RF utilizing powered toothbrush
    RF utilizing Powered toothbrush
    Other Name: RF toothbrush
  • Device: Control placebo with no RF
    Placebo control, with no RF
Study Arms  ICMJE
  • Experimental: Treatment group
    The treatment is conducted with the ToothWave toothbrush Intervention: brushing with RF-utilizing powered toothbrush
    Intervention: Device: RF utilizing powered toothbrush
  • Placebo Comparator: Control group
    Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
    Intervention: Device: Control placebo with no RF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2019)
86
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
90
Actual Study Completion Date  ICMJE April 15, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult subjects aged 18-70, that are in good health.
  2. 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.

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885323
Other Study ID Numbers  ICMJE DO116217A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Home Skinovations Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Home Skinovations Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffry L. Milleman, DDS, MPA Salus Research
PRS Account Home Skinovations Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP