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

April 2, 2023 updated by: Rambam Health Care Campus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus, Dept. of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Sham Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plaque score %
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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 %
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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)
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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
Time Frame: 4 weeks (T1), after 12 weeks (Tf)
the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing
4 weeks (T1), after 12 weeks (Tf)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

June 28, 2022

Study Completion (Actual)

June 28, 2022

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0352-20-RMB CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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