Safety and Efficacy of the ToothWave -12 Weeks Calculus Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04092075|
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis Plaque Calculus, Dental||Device: RF-utilizing powered toothbrush Device: Control placebo with no RF||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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 Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.|
|Actual Study Start Date :||August 7, 2019|
|Actual Primary Completion Date :||April 30, 2020|
|Actual Study Completion Date :||April 30, 2020|
Experimental: Treatment group
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush
Device: RF-utilizing powered toothbrush
RF-utilizing Powered toothbrush
Other Name: RF toothbrush
Sham Comparator: Control group
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Device: Control placebo with no RF
Placebo control, toothbrush with no RF
- Calculus [ Time Frame: 12 weeks ]A reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.
- Dental plaque [ Time Frame: 6 weeks ]A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.
- Gingival inflammation [ Time Frame: 6 weeks ]A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).
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): NCT04092075
|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|