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

NCT ID: NCT04640857

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-06-28

Brief Summary

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

Detailed 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.

Conditions

Oral Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Silk'n Toothwave

Intervention Type: 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.

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

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

Group Type: SHAM_COMPARATOR

Silk'n Toothwave

Intervention Type: 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.

Silk'n Toothwave with an electromagnetic field and without vibration

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

Group Type: ACTIVE_COMPARATOR

Silk'n Toothwave

Intervention Type: 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.

Interventions

Silk'n Toothwave

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hadar Zigdon, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Health Care Campus, Dept. of Periodontology

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 37515446 (View on PubMed)

Other Identifiers

0352-20-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id