Safety and Efficacy of the ToothWave -12 Weeks Calculus Study

Not Applicable

Completed

• Conditions: Gingivitis; Calculus, Dental; Plaque
• Interventions: Device: Control placebo with no RF; Device: RF-utilizing powered toothbrush

• Registration Number: NCT04092075
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-08-07
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-09-15
• Study First Posted: 2019-09-17
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control placebo with no RF	Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Treatment group	RF-utilizing powered toothbrush	The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush

Primary Outcome Measures

Name	Time	Method
Calculus	12 weeks	A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States