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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
91
RF-utilizing powered toothbrush for teeth whitening
regular powered toothbrush with no RF
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Extrinsic Stains
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.
Time frame: 6 weeks
Tooth color assessment
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.
Time frame: 6 weeks
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