Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)

Not Applicable

Completed

• Conditions: Tooth Discoloration
• Interventions: Device: powered toothbrush; Device: ToothWave

• Registration Number: NCT04092062
• Lead Sponsor: Home Skinovations Ltd.

Brief Summary

This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.

Detailed Description

The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.

One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA approved powered toothbrush (PTB)) will participate in the study.

For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group.

Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA accepted PTB and standard fluoride toothpaste.

Study Timeline

• Study Start: 2019-08-07
• Status Verified: 2019-09
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-09-15
• Study First Posted: 2019-09-17
• Primary Completion: 2020-01-28
• Study Completion: 2020-01-28
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - powered toothbrush	powered toothbrush	Subjects using a regular ADA-Accepted Powered Toothbrush, no RF
Treatment - ToothWave brush	ToothWave	Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.

Primary Outcome Measures

Name	Time	Method
Extrinsic Stains	6 weeks	Extrinsic Stains will be evaluated using the validated Lobene Stain Index (LSI); Stain Intensity score range is between 0 and 3, where: 0 = no stain; 1. = light stain; 2. = moderate stain; 3. = heavy stain; The mean stain intensity will be calculated for both the gingival and body regions of the incisor teeth for each subject.; Stain Area score rage is between 0 and 3, where: 0 = no stain; 1. = stain covering up to one third of region; 2. = stain covering up to two thirds of region; 3. = stain covering more than two thirds of region; The mean stain area will be calculated for both the gingival and body regions of the incisor teeth for each subject.

Secondary Outcome Measures

Name	Time	Method
Tooth color assessment	6 weeks	VITA Bleachedguide 3D-Master shade guide, includes 29 shade levels defined by the American Dental Association (ADA). These shade levels represents the brightness of the tooth where 1 is the whitest and 29 is the darkest shade.

Trial Locations

Locations (1)

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