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Safety and Efficacy of the ToothWave -12 Weeks Calculus 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: NCT04092075
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Home Skinovations Ltd.

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.

Condition or disease Intervention/treatment Phase
Gingivitis Plaque Calculus, Dental Device: RF-utilizing powered toothbrush Device: Control placebo with no RF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blind prospective study
Masking: Single (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).
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.
Actual Study Start Date : August 7, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Treatment group
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush
Device: RF-utilizing powered toothbrush
RF-utilizing Powered toothbrush
Other Name: RF toothbrush

Sham Comparator: Control group
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Device: Control placebo with no RF
Placebo control, toothbrush with no RF




Primary Outcome Measures :
  1. Calculus [ Time Frame: 12 weeks ]
    A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.


Secondary Outcome Measures :
  1. Dental plaque [ Time Frame: 6 weeks ]
    A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.

  2. Gingival inflammation [ Time Frame: 6 weeks ]
    A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092075


Locations
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United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
Home Skinovations Ltd.
Investigators
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Principal Investigator: Bennett T Amaechi, BDS, MS, PhD The University of Texas Health Science Center at San Antonio
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Responsible Party: Home Skinovations Ltd.
ClinicalTrials.gov Identifier: NCT04092075    
Other Study ID Numbers: DO116551A
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gingivitis
Dental Calculus
Calculi
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Pathological Conditions, Anatomical
Dental Deposits
Tooth Diseases