ToothWave Plaque and Gingivitis Study
|ClinicalTrials.gov Identifier: NCT03885323|
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : May 7, 2019
|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 effica-cy 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
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|