Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092075
• Other study ID #: DO116551A
• Status: Completed
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2020
• Source: Home Skinovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Calculus, Dental
• Dental Calculus
• Gingivitis
• Plaque

Intervention

Device:
• RF-utilizing powered toothbrush
RF-utilizing Powered toothbrush
• Control placebo with no RF
Placebo control, toothbrush with no RF

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Home Skinovations Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculus	A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.	12 weeks
Secondary	Dental plaque	A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.	6 weeks
Secondary	Gingival inflammation	A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).	6 weeks