Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
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|ClinicalTrials.gov Identifier: NCT04092062|
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : December 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tooth Discoloration||Device: ToothWave Device: powered toothbrush||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double arm, single blind prospective study|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The Outcomes Assessors will not be exposed to the type of brush the subject is using or to the group they are assigned to (treatment or control).|
|Official Title:||Safety and Efficacy of the ToothWave (Model H7001) Powered Toothbrush Home Use Device for Extrinsic Stain Reduction (Texas)|
|Actual Study Start Date :||August 7, 2019|
|Actual Primary Completion Date :||January 28, 2020|
|Actual Study Completion Date :||January 28, 2020|
Experimental: Treatment - ToothWave brush
Subjects using the Silk'n ToothWave, Radio frequency (RF)-utilizing toothbrush.
RF-utilizing powered toothbrush for teeth whitening
Other Name: RF toothbrush
Sham Comparator: Control - powered toothbrush
Subjects using a regular ADA-Accepted Powered Toothbrush, no RF
Device: powered toothbrush
regular powered toothbrush with no RF
- Extrinsic Stains [ Time Frame: 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
- = light stain
- = moderate stain
- = 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
- = stain covering up to one third of region
- = stain covering up to two thirds of region
- = 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.
- Tooth color assessment [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092062
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Bennett T Amaechi, BDS, MS, PhD||The University of Texas Health Science Center at San Antonio|