NCT05460091

Effect of High-Frequency Vibration on Periodontal Tooth Mobility

Completed Phase 1 Last updated 15 July 2022

What this trial tests

Phase 1 trial testing PTech Device in Tooth Mobility in 17 participants. Completed in 30 March 2022.

Timeline

1 July 2021

Primary endpoint
15 March 2022

30 March 2022

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	17
Start date	1 July 2021
Primary completion	15 March 2022
Estimated completion	30 March 2022
Sites	1 location across Canada

Drugs / interventions tested

• PTech Device
• PTech Sham Device

Conditions studied

• Tooth Mobility — all drugs for Tooth Mobility →

Sponsor

University of Alberta

Who can join

Adults 30 to 85, any sex, with Tooth Mobility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.