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

Primary Purpose

Oral Hygiene

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Silk'n Toothwave

About this trial

This is an interventional prevention trial for Oral Hygiene focused on measuring Electromagnetic Fields, Oral Hygiene

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Rambam Health Care Campus, Dept. of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

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

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

Silk'n Toothwave with an electromagnetic field and without vibration

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Plaque score %

to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors

Change in Calculus ratio %

to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software

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.

Secondary Outcome Measures

Probing depth mm

to measure the pocket depths around the anterior mandibular incisors

Bleeding on probing Yes/No

to document the presence or absence of bleeding of the dental pocket after probing

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

Subject satisfaction questionnaire

the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing

Full Information

NCT ID

NCT04640857

First Posted

November 1, 2020

Last Updated

April 2, 2023

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT04640857

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

December 15, 2020 (Actual)

Primary Completion Date

June 28, 2022 (Actual)

Study Completion Date

June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Hygiene

Keywords

Electromagnetic Fields, Oral Hygiene

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Experimental: Silk'n Toothwave

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Silk'n Toothwave with an electromagnetic field and without vibration

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Silk'n Toothwave

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Plaque score %

Description

to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors

Time Frame

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

Title

Change in Calculus ratio %

Description

to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software

Time Frame

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

Title

Change in Free gingival margin color (CEILAB color space)

Description

the color of the gingiva will be measured with the software Adobe photoshop and will be calculated with CIELAB color space.

Time Frame

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

Secondary Outcome Measure Information:

Title

Probing depth mm

Description

to measure the pocket depths around the anterior mandibular incisors

Time Frame

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

Title

Bleeding on probing Yes/No

Description

to document the presence or absence of bleeding of the dental pocket after probing

Time Frame

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

Title

Recession mm

Description

to measure the discrepancy (if existent) between the cementoenamel junction and the free gingival margin in the buccal aspect of the anterior mandibular incisors

Time Frame

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

Title

Subject satisfaction questionnaire

Description

the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hadar Zigdon, DMD

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Health Care Campus, Dept. of Periodontology

City

Haifa

ZIP/Postal Code

31096

Country

Israel

12. IPD Sharing Statement

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

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