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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
87
RF-utilizing Powered toothbrush
Placebo control, toothbrush with no RF
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Calculus
A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.
Time frame: 12 weeks
Dental plaque
A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.
Time frame: 6 weeks
Gingival inflammation
A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).
Time frame: 6 weeks
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