Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus

Study Overview
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Brief Summary
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to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus

Detailed Description
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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.

Official Title
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Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus

Conditions
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Oral Hygiene

Intervention / Treatment
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* Device: Silk'n Toothwave


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient aged 20-85 Years old Subject must have voluntarily signed the informed consent form before any study related action Presence of gingival inflammation (Gingival Index by Silness and Loe 1969) Presence of plaque on clinical crowns (calculation of area) Supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to T0 (baseline) Compliance with study schedules and arrival at study visits Exclusion Criteria: A systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers Pregnant or lactating women (*If Male Please write N/A). Heavy smokers (more than 10 cigarettes per day). Patients with a pacemaker that do not allow the use of an ultrasonic device. Patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study). Systemic condition requiring prophylactic antibiotics. Patients taking NSAIDS for prolonged period.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental: Silk'n Toothwave
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group: Silk'n Toothwave with vibration and electromagnetic field<br>Silk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months. | Device: Silk'n Toothwave<br>* 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.<br>|
| Sham Comparator: Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration)<br>Silk'n Toothwave without an electromagnetic field (only vibration ) use twice a day for 3 months. | Device: Silk'n Toothwave<br>* 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.<br>|
| Active Comparator: Silk'n Toothwave with an electromagnetic field and without vibration<br>Silk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months. | Device: Silk'n Toothwave<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic Fields, Oral Hygiene