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

NCT04640857 | Completed

• 1 other identifier: 0352-20-RMB CTIL
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Hygiene

Keywords

Electromagnetic Fields; Oral Hygiene

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Probing depth mm

  baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)

• Bleeding on probing Yes/No

  baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)

• Recession mm

  baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)

• Subject satisfaction questionnaire

  4 weeks (T1), after 12 weeks (Tf)

Study Arms (3)

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.

Device: Silk'n Toothwave

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.

Device: Silk'n Toothwave

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.

Device: Silk'n Toothwave

Interventions

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.

Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration); Silk'n Toothwave with an electromagnetic field and without vibration; Test group: Silk'n Toothwave with vibration and electromagnetic field

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

Location

Related Publications (1)

• 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.

  PMID: 37515446 DERIVED

Study Officials

• Hadar Zigdon, DMD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental: Silk'n Toothwave

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 23, 2020
• Study Start: December 15, 2020
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

IL (1)