GingivitisNCT04023097
Self-selection Study of the Toothwave Toothbrush
A study testing Toothwave toothbrush in people with Gingivitis and Plaque, run by Home Skinovations Ltd. at 1 site in United States.
Trial summary
This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque, Calculus
- What is being tested?
- Toothwave toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 9 Jul 2019
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female equal to or greater than 18 years of age.
- Subject is a potential candidate for purchasing the Silk'n Toothwave Device.
- Subject is capable of understanding and is willing to sign informed consent.
Who cannot join
- Current or history of oral cavity cancer or oropharyngeal cancer.
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Pregnant or nursing.
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
- Modified Inclusion Criteria for contraindicated subjects:
- Subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
- Subject is pregnant or nursing (lactating).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hellman Dermatology clinic
New York, New York, 10019
About this study
Official title: Self-selection Study to Confirm the "Toothwave" Labeling and User Manual Are Clear Enough for Contraindicated Users to Self-exclude Themselves From Using the Device
This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).
Read the detailed description
The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.
All subjects will sign an informed consent before any study activity. Five (5) potential end users and Additional five (5) contraindicated subjects will be screened for this self-selection study. Subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual).
Once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content.
The study will not include treatment.
- Conditions
- Gingivitis, Plaque, Calculus, Tooth Discoloration
- Being tested
- Toothwave toothbrush
- Medical subject headings
- Gingivitis, Plaque, Amyloid, Calculi, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothwave toothbrushDevice
Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Toothwave contraindicated subject | Experimental | the Toothwave toothbrush is contraindicated for people in certain conditions, e.g. pregnant or nursing women, people with pacemaker and more.
This arm is assembled from contraindicated subject, who should exclude themselves from use of the device, based on the user manual and box sleeve. Receives: Device: Toothwave toothbrush |
| potential users of the Toothwave device | Active comparator | The control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users. Receives: Device: Toothwave toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not.
Post-reading questionnaire includes the question: "are you allowed to use this device?". Based on reading the user manual and box labeling, subjects should answer "yes" or "no" according to their condition.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start2 Jul 2019
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Home Skinovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Hellman, MD, Principal investigator, Hellman Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023097
- Sponsor's protocol ID
- DO116508
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-selection Study to Confirm the "Toothwave" Labeling and User Manual Are Clear Enough for Contraindicated Users to Self-exclude Themselves From Using the Device
- ClinicalTrials.gov ID
- NCT04023097
- Acronym / sponsor ID
- DO116508
- Conditions
- Gingivitis, Plaque, Calculus, Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Home Skinovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 17 Jul 2019 (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.
This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).
Detailed description
The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.
All subjects will sign an informed consent before any study activity. Five (5) potential end users and Additional five (5) contraindicated subjects will be screened for this self-selection study. Subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual).
Once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content.
The study will not include treatment.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.
| Arm | Type | Receives |
|---|---|---|
| Toothwave contraindicated subject | Experimental | Device: Toothwave toothbrushthe Toothwave toothbrush is contraindicated for people in certain conditions, e.g. pregnant or nursing women, people with pacemaker and more. This arm is assembled from contraindicated subject, who should exclude themselves from use of the device, based on the user manual and box sleeve. |
| potential users of the Toothwave device | Active comparator | Device: Toothwave toothbrushThe control arm is assembled from people who can use the toothbrush and should recognize themselves as potential users. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is male or female equal to or greater than 18 years of age.
- Subject is a potential candidate for purchasing the Silk'n Toothwave Device.
- Subject is capable of understanding and is willing to sign informed consent.
Key exclusion criteria (8 listed)
- Current or history of oral cavity cancer or oropharyngeal cancer.
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Pregnant or nursing.
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
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 |
|---|---|---|
| Toothwave toothbrushSubjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires. | Device | Toothwave contraindicated subject, potential users of the Toothwave device |
Primary outcome
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not.
Time frame: 30 minutes
Post-reading questionnaire includes the question: "are you allowed to use this device?". Based on reading the user manual and box labeling, subjects should answer "yes" or "no" according to their condition.
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 24 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Judith Hellman, MD principal investigator
Hellman Dermatology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothwave toothbrush in people with Gingivitis and Plaque, run by Home Skinovations Ltd. at 1 site in United States.
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 3 inclusion and 8 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 24 Nov 2020. 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 United States. 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. 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?
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2020.