CompletedPhase 1

Effect of High-Frequency Vibration on Periodontal Tooth Mobility

Canada17 participantsStarted 2021-07-01

Plain-language summary

According to the CDC, approximately 47% of the population suffers from moderate or severe periodontitis. A byproduct of periodontal disease is loss of the alveolar bone surrounding the natural tooth root as well as around the dental implant in cases of peri-implantitis, and if allowed to proceed far enough, can cause mobility and eventual loss of the tooth or implant. Traditional and time-tested methods of treating periodontitis involve a meticulous mechanical cleaning of the root surfaces to remove the causing factors, both above and below the gumline. This reduction or elimination of the etiologic factors that trigger the pathologic and damaging immune response is very effective at reducing the inflammation. High Frequency Vibration (VPro+), when used as an adjunctive therapy following traditional treatment for periodontitis where the chronic inflammation has been lowered, controlled or eliminated has the potential to enhance the mechanical properties of the bone by increasing bone density by way of a low-risk, non-invasive, self-applied therapy that is patient-friendly and affordable. Improvement in bone density can translate clinically to lowering of tooth mobility, and lessening the chance of orthodontic relapse after orthodontic therapy. It is further hypothesized that, if conducted in an environment of low or nonexistent periodontal inflammation, VPro+ therapy may also contribute to enhanced the degree of bone fill after healing of angular periodontal bone defects and low-grade furcation involvements, and as thus may turn out to be a less invasive and more affordable option to periodontal bone grafting surgery, the current standard of care for those particular situations. The goal is to conduct a randomized clinical trial using patients in our graduate periodontology program to test the efficacy of high frequency vibration in improvement of tooth mobility and other periodontal indices in test group versus control group.

Who can participate

Age range

30 Years – 85 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Overall health must be either ASA Classification I or II. (ASA I: A normal healthy patient; ASA II: A patient with mild systemic disease) (Doyle, Goyal, \& EH, 2022),
. Patient must have a recent history of treated periodontal disease and currently be compliant with a periodontal recall maintenance program supervised by a periodontal specialist,
. Patient age must be between 30 and 85 years,
. No gender or ethnic restrictions,
. Patient must have at least one tooth with Miller's Class I mobility,
. Patients should have posterior dentition such that they can firmly hold the vibrating device, this likely implies the presence of two or more posterior teeth in all four quadrants.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tooth Mobility

Timeframe: 3 months of intervention after use of device for 5 minutes per night

Trial details

NCT IDNCT05460091

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-15

View on ClinicalTrials.gov More Tooth Mobility trials