ToothWave Plaque and Gingivitis 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: NCT03885323|
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : November 25, 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 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 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. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, 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 :||86 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single blind prospective study|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants will not know if the toothbrush is a treatment or control brush. Outcome assessor will be blinded as well and will not know which product was dispensed to which participant.|
|Official Title:||Safety and Efficacy of the Silk'n Toothbrush (ToothWave) Home Use Device for Reduction of Gingivitis, Dental Plaque and Calculus|
|Actual Study Start Date :||February 28, 2019|
|Actual Primary Completion Date :||April 15, 2019|
|Actual Study Completion Date :||April 15, 2019|
Experimental: Treatment group
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with RF-utilizing powered toothbrush
Device: RF utilizing powered toothbrush
RF utilizing Powered toothbrush
Other Name: RF toothbrush
Placebo Comparator: Control group
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Device: Control placebo with no RF
Placebo control, with no RF
- Dental plaque [ Time Frame: 6 weeks ]A reduction in the level of dental plaque according to Rustogi Modification of the Navy Plaque Index (RMNPI).
- Gingival inflammation [ Time Frame: 6 weeks ]A reduction in the level of gingival inflammation according to the Modified Gingival Index (MGI).
- Calculus [ Time Frame: 6 weeks ]A reduction of calculus deposits as evaluated by Volpe-Manhold Index
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): NCT03885323
|United States, Indiana|
|Fort Wayne, Indiana, United States, 46825|
|Principal Investigator:||Jeffry L. Milleman, DDS, MPA||Salus Research|