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to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus
Calculus is a white-brownish layer with various levels of stiffness, which accumulates on teeth and is formed by the mineralization of dental plaque.
Thus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque and calculus.
The electromagnetic field is known for bone healing by lessening osteoclast activity, improving osteoid formation, and stimulating angiogenesis. Furthermore, the electromagnetic field has an antimicrobial effect.
Electric toothbrushes have shown a statistical reduction in plaque accumulation and gingival inflammation.
Previous studies have shown that Silk'n Toothwave results in less plaque accumulation and calculus formation, in addition to stain removal and teeth whitening.
Study aim: to asses the effect of the electromagnetic field in a tooth brush (Silk'n Toothwave) on calculus accumulation and gingival parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group: Silk'n Toothwave with vibration and electromagnetic field | Experimental | Silk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months. |
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| Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration) | Sham Comparator | Silk'n Toothwave without an electromagnetic field (only vibration ) use twice a day for 3 months. |
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| Silk'n Toothwave with an electromagnetic field and without vibration | Active Comparator | Silk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silk'n Toothwave | Device | patients will receive a non-surgical treatment which will include oral hygiene instructions, calculus removal with ultrasonic and manual instruments. At the end of the meeting they will be provided with a toothbrush which is based on a radiofrequency technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque score % | to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors | baseline (T0), after 4 weeks (T1), after 12 weeks (Tf) |
| Change in Calculus ratio % | to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software | baseline (T0), after 4 weeks (T1), after 12 weeks (Tf) |
| Change in Free gingival margin color (CEILAB color space) | the color of the gingiva will be measured with the software Adobe photoshop and will be calculated with CIELAB color space. | baseline (T0), after 4 weeks (T1), after 12 weeks (Tf) |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth mm | to measure the pocket depths around the anterior mandibular incisors | baseline (T0), after 4 weeks (T1), after 12 weeks (Tf) |
| Bleeding on probing Yes/No | to document the presence or absence of bleeding of the dental pocket after probing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Zigdon, DMD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus, Dept. of Periodontology | Haifa | 31096 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37515446 | Derived | Khoury J, Giladi HZ, Ginesin O, Gabay E, Mayer Y. The influence of radio frequency-based toothbrush on the accumulation of calculus and periodontal health: A randomized double-blind controlled prospective study. Clin Exp Dent Res. 2023 Aug;9(4):574-585. doi: 10.1002/cre2.770. Epub 2023 Jul 29. |
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Experimental: Silk'n Toothwave
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| baseline (T0), after 4 weeks (T1), after 12 weeks (Tf) |
| Recession mm | to measure the discrepancy (if existent) between the cementoenamel junction and the free gingival margin in the buccal aspect of the anterior mandibular incisors | baseline (T0), after 4 weeks (T1), after 12 weeks (Tf) |
| Subject satisfaction questionnaire | the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing | 4 weeks (T1), after 12 weeks (Tf) |