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

Rambam Health Care Campus

Status: Completed

Conditions: Oral Hygiene

Treatments: Device: Silk'n Toothwave

Study type: Interventional

Funder types: Other

Identifiers

NCT04640857

0352-20-RMB CTIL

Details and patient eligibility

About

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

Full description

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.

Enrollment: 99 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups

Test group: Silk'n Toothwave with vibration and electromagnetic field

Experimental group

Description:

Silk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months.

Treatment:

Device: Silk'n Toothwave

Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration)

Sham Comparator group

Description:

Silk'n Toothwave without an electromagnetic field (only vibration ) use twice a day for 3 months.

Treatment:

Device: Silk'n Toothwave

Silk'n Toothwave with an electromagnetic field and without vibration

Active Comparator group

Description:

Silk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months.

Treatment:

Device: Silk'n Toothwave