ToothWave Plaque and Gingivitis Study

Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque; Calculus, Dental
• Intervention / Treatment: Device: RF utilizing powered toothbrush; Device: Control placebo with no RF

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: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; The treatment is conducted with the ToothWave toothbrush Intervention: brushing with RF-utilizing powered toothbrush	Device: RF utilizing powered toothbrush; RF utilizing Powered toothbrush; Other Names: RF toothbrush
Placebo Comparator: Control group; Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF	Device: Control placebo with no RF; Placebo control, with no RF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental plaque	A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).	6 weeks
Gingival inflammation	A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculus	A reduction of calculus deposits as evaluated by Volpe-Manhold Index	6 weeks

Collaborators and Investigators

• Sponsor: Home Skinovations Ltd.
• Investigators: Principal Investigator: Jeffry L. Milleman, DDS, MPA, Salus Research

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Calculi; Dental Calculus
• Other Study ID Numbers: DO116217A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No