An interventional study of RF-utilizing powered toothbrush and Control placebo with no RF in Gingivitis, Plaque and Calculus, Dental, sponsored by Home Skinovations Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-23.
Sponsored by Home Skinovations Ltd. · Not applicable, Interventional, and Treatment
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.
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 90 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Home Skinovations Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment is conducted with the ToothWave toothbrush Intervention: brushing with Radio frequency (RF)-utilizing powered toothbrush
Device: RF-utilizing powered toothbrush
Regular powered toothbrush Intervention: brushing with a regular powered toothbrush with no RF
Device: Control placebo with no RF
RF-utilizing Powered toothbrush
Also known as: RF toothbrush
Placebo control, toothbrush with no RF
Calculus
A significant calculus reduction in the treatment group as compared to the control group following 6 or 12 weeks of treatment.
Time frame: 6-12 weeks
reduction of calculus compared to baseline
reduction in the treatment group as compared to baseline following 12 weeks of treatment
Time frame: 6-12 weeks
Oral health
Subjective impression by study participants in their oral health status in the treatment group following 12 weeks of treatment.
Time frame: 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.
Time frame: 6-12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Dec 2020, 4 months.
Of 53 industry-sponsored interventional studies with no phase under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's 4 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Home Skinovations Ltd.