Oral HygieneNCT04640857
Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus
A study testing Silk'n Toothwave in people with Oral Hygiene, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Silk'n Toothwave
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2020to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Silk'n Toothwave
- Keywords
- Electromagnetic Fields, Oral Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk'n ToothwaveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Silk'n Toothwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque score %
to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors
Measured: 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
Measured: 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.
Measured: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Secondary outcomes (4)
Probing depth mm
to measure the pocket depths around the anterior mandibular incisors
Measured: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Bleeding on probing Yes/No
to document the presence or absence of bleeding of the dental pocket after probing
Measured: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
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
Measured: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Subject satisfaction questionnaire
the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing
Measured: 4 weeks (T1), after 12 weeks (Tf)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start15 Dec 2020
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Silk'n Toothwave
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadar Zigdon, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640857
- Sponsor's protocol ID
- 0352-20-RMB CTIL
- Status last verified
- Apr 2023
- First submitted
- 1 Nov 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37515446
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus
- ClinicalTrials.gov ID
- NCT04640857
- Acronym / sponsor ID
- 0352-20-RMB CTIL
- Conditions
- Oral Hygiene
- Keywords
- Electromagnetic Fields, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Experimental: Silk'n Toothwave
| Arm | Type | Receives |
|---|---|---|
| Test group: Silk'n Toothwave with vibration and electromagnetic field | Experimental | Device: Silk'n ToothwaveSilk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months. |
| Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration) | Sham comparator | Device: Silk'n ToothwaveSilk'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 | Active comparator | Device: Silk'n ToothwaveSilk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk'n Toothwavepatients 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. | Device | 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 |
Primary outcome
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
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
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.
4 secondary outcomes
Probing depth mm
Time frame: 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)
Recession mm
Time frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Subject satisfaction questionnaire
Time frame: 4 weeks (T1), after 12 weeks (Tf)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 37515446Khoury 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Zigdon, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silk'n Toothwave in people with Oral Hygiene, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque score % (time frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04640857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.