GingivitisNCT04596761
ToothWave Calculus Reduction and Accumulation Prevention Study
A study testing RF-utilizing powered toothbrush in people with Gingivitis and Plaque, run by Home Skinovations Ltd. at 1 site in United States.
Trial summary
The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque, Calculus, Dental
- What is being tested?
- RF-utilizing powered toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 10 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects aged 18 years and older, that are in good health.
- Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
- The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
- The subjects should be willing to comply with the study procedures and schedule, including the follow up visits.
- Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.
Who cannot join
- Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
- Regular users of a chlorhexidine mouthrinse.
- Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
- 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 by subject report.
- Subjects that do not brush regularly.
- Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation
The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.
Read the detailed description
This is a parallel group, single-blind, randomized, and controlled prospective study aimed to evaluate the safety and efficacy of the ToothWave in calculus reduction and prevention of calculus accumulation.
Eligible subjects will undergo a dental prophylaxis, and will enter a two-month run-in phase. A Volpe-Manhold Index (V-MI) calculus examination will be per-formed at the end of the run-in phase. A minimum of 90 qualified subjects (completers) who will form at least 9 mm of calculus on the lingual surface of the mandibular anterior teeth and will qualify to continue participation ac-cording to the eligibility criteria and will be randomly assigned to either the ToothWave or the control brush (ADA-accepted powered TB) group. Subjects will be stratified according to calculus levels (which indicates the calculus growth rate). Stratification will also be conducted according to age, gender, and ethnic group. Subjects will brush twice daily, unsupervised, during a three-month test period, returning at Weeks 3, 6 and 12 for safety and V-MI examinations. An additional visit will be conducted at week 9, during which a supervised brushing will be conducted.
The study test phase will include a total of 168 treatment sessions and 5 clinic visits over a period of 12 weeks.
For each subject, assessment data will be collected at baseline, and at 3, 6 and 12 weeks of the test phase. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the ToothWave and standard fluoride toothpaste. The control group will use a regular powered toothbrush and standard fluoride toothpaste.
- Conditions
- Gingivitis, Plaque, Calculus, Dental
- Being tested
- RF-utilizing powered toothbrush, Control placebo with no RF
- Medical subject headings
- Gingivitis, Plaque, Amyloid, Dental Calculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF-utilizing powered toothbrushDevice
Also called RF toothbrush
RF-utilizing Powered toothbrush
Control placebo with no RFDevice
Placebo control, toothbrush with no RF
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush Receives: Device: RF-utilizing powered toothbrush |
| Control group | Experimental | Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF Receives: Device: Control placebo with no RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculus
A significant calculus reduction in the treatment group as compared to the control group following 6 or 12 weeks of treatment.
Measured: 6-12 weeks
Secondary outcomes (3)
reduction of calculus compared to baseline
reduction in the treatment group as compared to baseline following 12 weeks of treatment
Measured: 6-12 weeks
Oral health
Subjective impression by study participants in their oral health status in the treatment group following 12 weeks of treatment.
Measured: 12 weeks
prevention of calculus accumulation
prevention of calculus accumulation in the treatment group as seen by no significant increase in calculus score as compared to baseline.
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Jul 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind prospective study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Home Skinovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L Milleman, DDS, MPA, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596761
- Sponsor's protocol ID
- DO117427A
- Status last verified
- Mar 2020
- First submitted
- 15 Oct 2020
- Last updated
- 23 Apr 2021
- 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 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the ToothWave™ (Model H7001) Home Use Device for Calculus Reduction and Prevention of Calculus Accumulation
- ClinicalTrials.gov ID
- NCT04596761
- Acronym / sponsor ID
- DO117427A
- Conditions
- Gingivitis, Plaque, Calculus, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Home Skinovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 22 Oct 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.
The objective of the study is to evaluate the safety and efficacy of the home-use device ToothWave (Model H7001) for calculus reduction and the prevention of calculus accumulation.
Detailed description
This is a parallel group, single-blind, randomized, and controlled prospective study aimed to evaluate the safety and efficacy of the ToothWave in calculus reduction and prevention of calculus accumulation.
Eligible subjects will undergo a dental prophylaxis, and will enter a two-month run-in phase. A Volpe-Manhold Index (V-MI) calculus examination will be per-formed at the end of the run-in phase. A minimum of 90 qualified subjects (completers) who will form at least 9 mm of calculus on the lingual surface of the mandibular anterior teeth and will qualify to continue participation ac-cording to the eligibility criteria and will be randomly assigned to either the ToothWave or the control brush (ADA-accepted powered TB) group. Subjects will be stratified according to calculus levels (which indicates the calculus growth rate). Stratification will also be conducted according to age, gender, and ethnic group. Subjects will brush twice daily, unsupervised, during a three-month test period, returning at Weeks 3, 6 and 12 for safety and V-MI examinations. An additional visit will be conducted at week 9, during which a supervised brushing will be conducted.
The study test phase will include a total of 168 treatment sessions and 5 clinic visits over a period of 12 weeks.
For each subject, assessment data will be collected at baseline, and at 3, 6 and 12 weeks of the test phase. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the ToothWave and standard fluoride toothpaste. The control group will use a regular powered toothbrush and standard fluoride toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind prospective study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: RF-utilizing powered toothbrushThe treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush |
| Control group | Experimental | Device: Control placebo with no RFRegular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects aged 18 years and older, that are in good health.
- Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
- The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
- The subjects should be willing to comply with the study procedures and schedule, including the follow up visits.
- Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.
Key exclusion criteria (8 listed)
- Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
- Regular users of a chlorhexidine mouthrinse.
- Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
- Current or history of oral cavity cancer or oropharyngeal cancer.
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
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 |
|---|---|---|
| RF-utilizing powered toothbrushAlso: RF toothbrushRF-utilizing Powered toothbrush | Device | Treatment group |
| Control placebo with no RFPlacebo control, toothbrush with no RF | Device | Control group |
Primary outcome
Calculus
Time frame: 6-12 weeks
A significant calculus reduction in the treatment group as compared to the control group following 6 or 12 weeks of treatment.
3 secondary outcomes
reduction of calculus compared to baseline
Time frame: 6-12 weeks
Oral health
Time frame: 12 weeks
prevention of calculus accumulation
Time frame: 6-12 weeks
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 23 Apr 2021.
- 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.
Jeffery L Milleman, DDS, MPA principal investigator
Salus Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF-utilizing powered 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 5 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 23 Apr 2021. 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?
Calculus (time frame: 6-12 weeks). 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 23 Apr 2021.