Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction
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|ClinicalTrials.gov Identifier: NCT03885609|
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tooth Discoloration||Device: ToothWave Device: powered toothbrush||Not Applicable|
The study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.
One treatment group (Silk'n power toothbrush - ToothWave) and 1 control group (an ADA approved power 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 manufactur-er'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 ac-cepted PTB and the same standard fluoride toothpaste.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 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 Power Toothbrush for Extrinsic Stain Reduction|
|Actual Study Start Date :||February 28, 2019|
|Actual Primary Completion Date :||April 12, 2019|
|Actual Study Completion Date :||April 12, 2019|
Experimental: Treatment - toothwave brush
Subjects using the Silk'n ToothWave RF utilizing toothbrush
RF-utilizing powered toothbrush for teeth whitening
Other Name: RF toothbrush
Sham Comparator: Control - powered toothbrush
Subject using a regular powered toothbrush with 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885609
|United States, Indiana|
|Fort Wayne, Indiana, United States, 46825|
|Principal Investigator:||Jeffery L Milleman, DDS, MPA||Salus research center|