Accelerated Invisalign Therapy in Conjunction With Acceledent Aura
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Purpose:

      The objective of this study is to investigate the effects of accelerated Invisalign and
      vibration therapy on rate of orthodontic tooth movement, activation of inflammation
      biomarkers as well as pain levels experienced by orthodontic patients during the initial 12
      weeks of alignment.

      Participants:

      Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency
      Program will be recruited for this study. Patients older than 18 years old will be otherwise
      healthy subjects previously diagnosed with malocclusion.

      Procedures (methods):

      Each patient will be randomly allocated into either a control group or one of two
      intervention groups. Patients within the control group will receive standard Invisalign
      therapy without vibration. Patients within the intervention groups will receive accelerated
      Invisalign therapy with or without vibration. Patients receiving vibration therapy will
      utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30
      Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's
      dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks
      progress visits.
    

Detailed description: 
      Align Technology©, Inc. developed Invisalign® in 1997 to meet the esthetic demands of
      orthodontic patients and providers. Invisalign patients receive a series of computer-assisted
      designed stereolithic clear retainers to incrementally resolve their malocclusion.
      Invisalign® and other advances in orthodontic technology such as clear aligners, ceramic
      brackets and lingual braces offer options to address the esthetic demands of most orthodontic
      patients but duration of treatment continues to be one of the most challenging aspects of
      practice.

      In 2008, OrthoAccel Technologies©, Inc. developed the AcceleDent device to accelerate tooth
      movement and reduce orthodontic treatment time. Patients receiving vibration therapy are
      instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 N (25 grams)
      force level with a 30 Hz frequency for 20 minutes per day. The theory underlying AcceleDent
      and the use of vibration to expedite orthodontic tooth movement started in 1892 with the
      studies of Julius Wolff, who discovered bone adapts to pressure loads. In 2001, Astronauts in
      space attempted to use the principles of Wolff's Law to maintain normal bone quality by
      working out and performing daily tasks while standing on a vibrating plate with the aid of
      elastic straps. In 2004, the effect of vibration therapy on bone density was further
      supported when increased bone density and strength was noted in post-menopausal women who
      received whole body vibration therapy. OrthoAccel claims vibration therapy using the
      AcceleDent device can reduce treatment time up to 50 percent by accelerating the process of
      bone remodeling required for orthodontic tooth movement. In 2013, despite relatively little
      scientific evidence, the US Food and Drug Administration (FDA) approved AcceleDent as a class
      II medical device and orthodontic accessory to facilitate accelerated tooth movement.

      Invisalign therapy in conjunction with AcceleDent has been aggressively marketed towards the
      esthetically sensitive patient who, not so coincidentally, is the most concerned with
      duration of treatment. Some orthodontic providers using vibration therapy have deviated from
      the standard 2-week aligner schedule and recommend a 4-day aligner schedule. Orthodontic
      patients receiving accelerated Invisalign therapy in conjunction with AcceleDent claim
      reduced treatment time by as much as 50 percent. What is responsible for the positive
      results? The accelerated tooth movement might simply be the result of the accelerated
      Invisalign therapy, which would raise the question of whether vibration therapy and the cost
      associated with AcceleDent is justified. The purpose and primary specific aim of our study
      will be to determine the cause of the accelerated tooth movement. Because the vibration
      therapy is used in conjunction with an accelerated Invisalign aligner schedule, there is an
      assumption that the vibration therapy is promoting faster tooth movement. However, the
      current literature, from clinical trials, supporting the efficacy of vibration therapy on
      accelerated tooth movement is lacking.

      Accelerated orthodontic tooth movement may offer many benefits to both, the patient and the
      orthodontist. Reduced treatment time reduces the burden of orthodontic treatment by
      decreasing risk for undesired treatment sequelae (e.g., white spot lesion, caries,
      gingivitis, etc) and potentially reduces the discomfort commonly associated with orthodontic
      treatment. Orthodontists benefit from accelerated tooth movement for multiple reasons
      pertaining to practice management and increased profitability. Orthodontists using
      accelerated treatment techniques have reported increased profit margins due to reduced chair
      time and increased organic growth due to differentiation of the practice.

      There are also potential negative outcomes associated with accelerated orthodontic tooth
      movement. For the patient, there is a potential increased risk for root resorption, increased
      treatment fees and pain associated with treatment. At this time, there is no published data
      regarding the potential for orthodontic relapse following the accelerated orthodontic tooth
      movement. There are several publications supporting the fact that relapse is a known risk for
      conventional orthodontic treatment. The investigators can make the safe assumption that
      accelerated orthodontic treatment would be no different than conventional orthodontic therapy
      with regard to relapse potential. All orthodontic patients must be compliant with regard to
      orthodontic retention or relapse will be expected. Most orthodontists are charging between
      $700-800 for AcceleDent therapy in addition to the normal orthodontic fee. Finally, there is
      no published data regarding pain associated with accelerated Invisalign treatment.

      Further, the mechanism underlying any increased orthodontic tooth movement due to vibration
      remains unclear. Studies on a cellular level have shown a promising but complicated mechanism
      of how vibration may enhance activation of various cell proliferation and differentiation
      molecules within the periodontal ligament (PDL) stem cells as well as increase levels of
      gingival inflammation biomarkers. For example, vibration therapy might accelerate breakdown
      of the cellular cytoskeleton, increase actinG trafficking into the nucleus, increase Runx2
      gene expression, and thus facilitate bone formation. Whether this mechanotransduction
      mechanism can be translated into clinical tooth movement is unknown and its clinical evidence
      remains to be elucidated.

      In this study, the investigators propose a randomized prospective clinical design to
      investigate effects of AcceleDent vibration therapy on the efficiency of tooth movement, on
      the activation of gingival crevicular fluid biomarkers and on patient discomfort in
      conjunction with accelerated Invisalign therapy.
    

Intervention name(s): AcceleDent Aura; Accelerated Invisalign therapy
Intervention type(s): Device; Device
Intervention description(s): Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.; Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment