ToothWave Calculus Reduction and Accumulation Prevention Study

Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation

The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.

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 parallel group, single-blind, randomized, and controlled prospective study aimed to evaluate the safety and efficacy of the ToothWave in calculus reduction and prevention of calculus accumulation.

Eligible subjects will undergo a dental prophylaxis, and will enter a two-month run-in phase. A Volpe-Manhold Index (V-MI) calculus examination will be per-formed at the end of the run-in phase. A minimum of 90 qualified subjects (completers) who will form at least 9 mm of calculus on the lingual surface of the mandibular anterior teeth and will qualify to continue participation ac-cording to the eligibility criteria and will be randomly assigned to either the ToothWave or the control brush (ADA-accepted powered TB) group. Subjects will be stratified according to calculus levels (which indicates the calculus growth rate). Stratification will also be conducted according to age, gender, and ethnic group. Subjects will brush twice daily, unsupervised, during a three-month test period, returning at Weeks 3, 6 and 12 for safety and V-MI examinations. An additional visit will be conducted at week 9, during which a supervised brushing will be conducted.

The study test phase will include a total of 168 treatment sessions and 5 clinic visits over a period of 12 weeks.

For each subject, assessment data will be collected at baseline, and at 3, 6 and 12 weeks of the test phase. 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 ToothWave and standard fluoride toothpaste. The control group will use a regular powered toothbrush and standard fluoride toothpaste.

• Study Type: Interventional
• Enrollment (Actual): 90
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Adult subjects aged 18 years and older, that are in good health.
2. Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
3. 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.
4. The subjects should be willing to comply with the study procedures and schedule, including the follow up visits.
5. Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.

Exclusion Criteria

1. Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
2. Regular users of a chlorhexidine mouthrinse.
3. Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
4. Current or history of oral cavity cancer or oropharyngeal cancer.
5. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
6. Pregnant or nursing by subject report.
7. Subjects that do not brush regularly.
8. 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: 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
Experimental: 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 significant calculus reduction in the treatment group as compared to the control group following 6 or 12 weeks of treatment.	6-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of calculus compared to baseline	reduction in the treatment group as compared to baseline following 12 weeks of treatment	6-12 weeks
Oral health	Subjective impression by study participants in their oral health status in the treatment group following 12 weeks of treatment.	12 weeks
prevention of calculus accumulation	prevention of calculus accumulation in the treatment group as seen by no significant increase in calculus score as compared to baseline.	6-12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: March 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: DO117427A

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