Effect of High-Frequency Vibration on Periodontal Tooth Mobility

NCT05460091 | Completed Phase 1

• 1 other identifier: Pro00102774
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Mobility

Keywords

vibration; high-frequency; high frequency; effect

Outcome Measures

Primary Outcomes (1)

• Tooth Mobility

  Change in tooth mobility as denoted by Periotest value or Miller's grade of mobility

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

Secondary Outcomes (1)

• Bone mineral density (BMD)

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

Study Arms (2)

Control Group

SHAM COMPARATOR

Control group - sham Ptech device(does not vibrate)

Device: PTech Sham Device

Test group

ACTIVE COMPARATOR

Test group - active Ptech device (High-Frequency Vibrational device)

Device: PTech Device

Interventions

PTech Device DEVICE

High-frequency vibration device used on regular basis in orthodontics

Test group

PTech Sham Device DEVICE

sham device (does not vibrate)

Control Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients on medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers,
• Periodontal recall patients who have a history of non-compliance with the recommended recall interval (usually three to four months),
• Pregnant women,
• Uncontrolled diabetes,
• Smoking,
• Subjects with current caries activity,
• Vulnerable subjects as per the Research Ethics Office or HREB definitions.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

School of Dentistry, Oral health Clinic, University of Alberta

Edmonton, Alberta, T6G 1Z1, Canada

Location

Related Publications (5)

• Carroll JD, Milward MR, Cooper PR, Hadis M, Palin WM. Developments in low level light therapy (LLLT) for dentistry. Dent Mater. 2014 May;30(5):465-75. doi: 10.1016/j.dental.2014.02.006. Epub 2014 Mar 21.

  PMID: 24656472 BACKGROUND

• El-Bialy T, Farouk K, Carlyle TD, Wiltshire W, Drummond R, Dumore T, Knowlton K, Tompson B. Effect of Low Intensity Pulsed Ultrasound (LIPUS) on Tooth Movement and Root Resorption: A Prospective Multi-Center Randomized Controlled Trial. J Clin Med. 2020 Mar 16;9(3):804. doi: 10.3390/jcm9030804.

  PMID: 32188053 BACKGROUND

• Alikhani M, Alansari S, Hamidaddin MA, Sangsuwon C, Alyami B, Thirumoorthy SN, Oliveira SM, Nervina JM, Teixeira CC. Vibration paradox in orthodontics: Anabolic and catabolic effects. PLoS One. 2018 May 7;13(5):e0196540. doi: 10.1371/journal.pone.0196540. eCollection 2018.

  PMID: 29734391 BACKGROUND

• Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ; CDC Periodontal Disease Surveillance workgroup: James Beck (University of North Carolina, Chapel Hill, USA), Gordon Douglass (Past President, American Academy of Periodontology), Roy Page (University of Washin. Prevalence of periodontitis in adults in the United States: 2009 and 2010. J Dent Res. 2012 Oct;91(10):914-20. doi: 10.1177/0022034512457373. Epub 2012 Aug 30.

  PMID: 22935673 BACKGROUND

• Friedewald VE, Kornman KS, Beck JD, Genco R, Goldfine A, Libby P, Offenbacher S, Ridker PM, Van Dyke TE, Roberts WC; American Journal of Cardiology; Journal of Periodontology. The American Journal of Cardiology and Journal of Periodontology editors' consensus: periodontitis and atherosclerotic cardiovascular disease. J Periodontol. 2009 Jul;80(7):1021-32. doi: 10.1902/jop.2009.097001.

  PMID: 19563277 BACKGROUND

MeSH Terms

Conditions

Tooth Mobility

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Graduate student and PI were double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot RCT. We had a test group and a control group

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 15, 2022
• Study Start: July 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 30, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)