Effect of High-Frequency Vibration on Periodontal Tooth Mobility
Condition: Tooth Mobility
MeSH terms: Tooth Mobility
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Background Bio stimulation of hard and soft tissue to enhance or accelerate healing is an
      exciting area of inquiry with the potential to have broad clinical application in
      periodontics. The external application of energy in the form of light (e.g. Lasers or
      broad-spectrum light) (1) or mechanical waves (ultrasonic or high-frequency vibration)
      (2),(3) has shown efficacy in creating clinical changes in hard and soft tissue that can be
      very positive and beneficial or the contrary, depending on the application and the existing
      initial conditions present. According to the CDC, approximately 47% of the population suffers
      from moderate or severe periodontitis. (4) This chronic disease is a systemic disease that is
      fundamentally connected to other diseases of inflammation, including diabetes, arthritis,
      Alzheimer's Disease, and heart disease(5) and is, therefore, a disease that should not be
      taken lightly. A by-product of periodontal disease is the 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 dental implant. The chronic inflammatory process results in the destruction
      of both hard and soft tissues and is triggered in the susceptible host by microbial biofilm
      and mineralized biofilm (i.e. calculus).

      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 gum
      line. This reduction or elimination of the etiologic factors that trigger the pathologic and
      damaging immune response is very effective at reducing inflammation. High-Frequency Vibration
      (VPro+), when used as an adjunctive therapy following traditional treatment for periodontitis
      wherein the chronic inflammation has been lowered, controlled, or eliminated has the
      potential to enhance the mechanical properties of the bone by increasing bone density (3) 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 (i.e.
      improvement) 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 enhancing 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.

      Tissue Response to VPro+ Application in areas of Inflammation It is clear from previous
      research into the use of the VPro+ to accelerate and enhance orthodontic therapy that the
      cellular tissue response in areas of inflammation is essentially the opposite to that which
      occurs in areas of no inflammation. (3) Again, whether the response is beneficial depends on
      the intended application at hand. VPro+ therapy in areas of inflammation caused by
      orthodontic tooth movement forces stimulates osteoclastic activity to accelerate the
      resorption of bone, making the bone "softer" and thus allowing for more rapid tooth movement
      through these softer areas. On the contrary, when considering periodontitis, it is critical
      to understand that the inflammation must first be lowered and controlled so that the tissue
      response is anabolic, not catabolic. Our goal in periodontal therapy is to preserve,
      regenerate and strengthen the periodontal tissues, including the bone. So, a mandatory
      precursor therapy to using the VPro+ in cases of periodontitis is to first perform
      periodontal therapy and demonstrate and document a reduction or elimination of chronic
      inflammation by way of a Re-Evaluation Examination.

      Expected result of this study We expect that VPro+ will safely enhance the condition of the
      periodontal tissues around the teeth in periodontal patients in a periodontal recall program
      and that this enhancement will improve the long-term prognoses of the teeth.

      Study design This randomized, single blind clinical trial will enroll from 10-20 subjects
      from an established graduate periodontology program who have previously been treated for
      periodontal disease and are now in a periodontal recall program. These patients will be
      randomized between the two groups. The evaluator examining the patients will be blinded to
      the group assignment as the coding will be kept separate from the clinical patient record.
      The subjects, however, will be aware of whether they are in the treatment or no-treatment
      control group.

      Specific Aims of the study:

      This clinical trial aims to answer these questions:

        1. Will the vibration produced by the VPro+ device improve (i.e. lessen) the mobility of
           periodontally compromised teeth for periodontal patients in a periodontal recall
           program?

        2. Will the vibration produced by the VPro+ device improve the periodontal condition around
           teeth as measured by the standard periodontal indices in periodontal patients who are in
           a periodontal recall program?

        3. Will the vibration produced by the VPro+ device improve the appearance of angular bone
           defects on routine radiographs (i.e. give the appearance of partial or complete fill of
           the bone defect) in periodontal patients in a periodontal recall program?

        4. Will the vibration produced by the VPro+ device improve (i.e. increase) the bone density
           as measured by CBCT analysis in periodontal patients in a periodontal recall program?
           Study Groups

      To address this specific aim, patient will be divided into 2 groups:

      Group 1 (Treatment) This group will use the VPro+ device for 5 minutes every night for 3
      months Group 2 (No Treatment) This group will be given a sham VPro+ device and thus serve as
      the control group.

      Methods and procedures This is a randomized, single blinded clinical trial. The subjects will
      be patients with a history of treated periodontal disease that are currently in and compliant
      with a periodontal recall program in an established periodontal specialty practice. The
      subjects will be randomized between 2 groups. Group 1 is the treatment group and will receive
      the VPro+ device to use 5 minutes per night for 3 months. Group 2 is the no-treatment
      (control) group that will have access to the sham VPro+ device. Patient will be asked to bite
      comfortably on VPro+ for a total of 5 minutes per day, preferably just before bedtime.
      Compliance will be collected from the VPro+ using the Propel Application on the subjects'
      smartphone.

      Data collection, data analysis and monitoring A designated clinical study coordinator will be
      assigned by the Principal Investigator. Good Clinical Practices (GCP) will be implemented for
      this study. The designee will review the Case Report Forms (CRF) for completeness and assess
      them for any product complaints, potential adverse events and/or medical device reports per
      the Health Canada regulations. Any missing entries in the CRFs will be brought to the
      Investigator or study coordinator's attention for correction.

      Potential Benefits to the Subject In patients with periodontal disease and bone loss that
      have already been treated by traditional methods, we anticipate that the bone density and
      mechanical properties of the bone may increase (i.e. improve) in patients receiving HFV
      therapy. This can have the effect of lowering the mobility of some of the teeth. Even so, the
      subject may not get any benefit from being in this research study. This study may help people
      in the future who are in periodontal recall programs. Subjects (i.e. patients) who complete
      the study will not be charged for any of the care delivered during the study. Once the study
      is over, patients will go back on their normal periodontal recall program.
    

Intervention name(s): PTech Device; PTech Sham Device
Intervention type(s): Device; Device
Intervention description(s): High-frequency vibration device used on regular basis in orthodontics; sham device (does not vibrate)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot RCT. We had a test group and a control group
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vibration; high-frequency; high frequency; effect