Clinical Studies

About the Study

This is an open label, prospective pilot study aimed to evaluate the safety and efficacy of the Silk'n toothbrush.  The study included 14 subjects that performed 120 treatment sessions, over a period of 2 months.  Each subject served as his/her own control, while comparing results before treatment, and after 2 months of treatment. An interim analysis was conducted as well following one month of treatment. Treatment was defined as 2 minutes brushing of the teeth in a regular manner, twice a day (morning and evening). Brushing was conducted using the Silk’n toothbrush and a regular marketed toothpaste (Colgate advanced clean)

About the Study

Objective:

To evaluate the effect of ToothWave™ a novel RF-utilizing toothbrush on plaque, calculus and gingival inflammation as compared to a control standard ADA-approved powered toothbrush.  

Methods:

This was a single-blind double arm prospective study, including 4 clinical visits that were conducted every two weeks. Subjects were randomized to one of two study groups, receiving either the Silk’n ToothWave™ or control toothbrush, and performed twice daily brushing during a test period of 6 weeks. Plaque, calculus, gingival inflammation and bleeding were assessed using the RMNPI, V-MI, MGI, and GBI measures, at baseline and after 4 and 6 weeks (visits 3 and 4 respectively) of brushing. Results (mean scores) were compared within each group between the different visits and between the groups; delta values (reduction from baseline) of each score were also compared between the groups. Statistical analyses were conducted using the Mann Whitney non-parametric model.

Results:

A total of 85 subjects (44 in the treatment group and 41 in the control) completed the study, having fully evaluable data. At baseline, the test groups did not differ significantly in the efficacy measurements mean scores (p≥0.165). Following 6 weeks of brushing the test group showed significant reductions in all the tested measures as compared to the control group. In addition, the reduction from baseline of all measured scores were significantly greater in the treatment group as compared to the control (p≤0.001). Both toothbrushes were well-tolerated and no device related adverse events were reported during the study

Conclusions: 

The Silk’n ToothWave™ RF-utilizing toothbrush produced significant benefits in reduction of plaque, calculus, gingivitis and bleeding as compared to a control, ADA-approved powered toothbrush. 

About the Study

Objective:

To evaluate the effect of ToothWave™ a novel RF-utilizing toothbrush on teeth stains and shade as compared to a control standard ADA-approved powered toothbrush.

Methods:
This was a single-blind double arm prospective study, including 4 clinical visits that were conducted every two weeks. Subjects were randomized to one of two study groups, receiving either the Silk’n ToothWave™ or control toothbrush, and performed twice daily brushing during a test period of 6 weeks. Teeth stains and shade were assessed using the Lobene stain index and Vita bleachguide 3D Master, at baseline and after 4 and 6 weeks (visits 3 and 4 respectively) of brushing. Results (mean scores) were compared within each group between the different visits and between the groups; delta values (reduction from baseline) of each score were also compared between the groups. Statistical analyses were conducted using the Mann Whitney non-parametric model.

Results:
A total of 84 subjects (41 in the treatment group and 43 in the control) completed the study, having fully evaluable data. At baseline, the test groups did not differ significantly in the efficacy measurements mean scores (p≥0.776). Following 6 weeks of brushing the test group showed significant reductions in all the tested measures as compared to the control group. In addition, the reduction from baseline of the measured scores were significantly greater in the treatment group as compared to the control (p≤0.001). Both toothbrushes were well-tolerated and no device related adverse events were reported during the study.

Conclusions:
The ToothWave™ RF-utilizing toothbrush produced significant benefits in reduction of teeth stains and whitening of teeth shade as compared to a control, ADA-approved powered toothbrush.

About the Study

The objective of the study was to evaluate, histologically a possible negative effect that might be a result of repeated usage of an oral medical device in swine teeth and gingiva. Teeth of three animals (10 teeth per animal) were fixated, decalcified and prepared in Pharmaseed and trimmed in proper cassettes (30 samples in total). In all 30 teeth samples no pathological changes were observed. Therefore, it can be concluded that the oral medical device was compatible and had no safety problem or other negative effect.

Key Personnel:

Histopathologist: Emmanuel Loeb, Vet. Path Specialist

Quality Assurance: Noa Bischitz M.Sc. CMQ/OE.

Sponsor: Liora Levi (ph.D.)