Accelerated Invisalign Therapy in Conjunction With Acceledent Aura

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 Wollf, 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.

Inclusion Criteria:

1. Males or females over the age of 18 years old desiring orthodontic treatment.

2. Adult dentition with all upper and lower front teeth present and any premolar and
molar combination in the upper posterior of two teeth on each side.

3. Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.

4. Good health as determined by medical history.

5. Willingness and ability to comply with study procedures, attend study visits, and
complete the study.

6. The ability to understand and sign a written informed consent form, which must be
signed prior to initiation of study procedures.

Exclusion Criteria:

1. Patient under the age of 18 years old

2. Women may not be pregnant. Negative urine pregnancy tests prior to exposure to cone
beam imaging is required to verify pregnancy status.

3. Patients diagnosed with systemic diseases such as diabetes, hypertension (high blood
pressure), temporomandibular disorders (jaw disorders), or craniofacial syndromes.

4. Severe malocclusions that would require adjunctive procedures other than Invisalign.
These include impacted teeth, closure of extractions spaces.

5. Significant periodontal disease (> 4mm pocket depth or >2 mm of recession on upper
anterior teeth).

6. Active caries not under care of either a dentist or periodontist.

7. Chronic daily use of any non-steroidal anti-inflammatory medication, estrogen,
calcitonin, or corticosteroids.

8. History of use or current use of any bisphosphonate medication or other medication for
treatment of osteoporosis.

9. Current smoker (must not have smoked in the last 6 months).

10. Failing to comply with research protocols