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 to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-29.
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 Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.
This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.
The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks.
One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.
For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. 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 Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 87 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.
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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.
Subject must have:
2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of ≥1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).
2.4. Total Calculus deposits greater than 9 according to the Volpe-Manhold Index.
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 reduction of calculus deposits as compared to control, as evaluated by Volpe-Manhold Index.
Time frame: 12 weeks
Dental plaque
A reduction in the level of dental plaque compared to control, according to Rustogi Modification of the Navy.
Time frame: 6 weeks
Gingival inflammation
A reduction in the level of gingival inflammation compared to control, according to the Modified Gingival Index (MGI).
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Home Skinovations Ltd.