Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

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

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 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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio

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:

   2.1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

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 Radio frequency (RF)-utilizing powered toothbrush	Device: RF-utilizing powered toothbrush; RF-utilizing Powered toothbrush; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculus	A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Home Skinovations Ltd.
• Investigators: Principal Investigator: Bennett T Amaechi, BDS, MS, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 7, 2019
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: September 15, 2019
• First Posted (ACTUAL): September 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

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: DO116551A

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