Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

There are many variables that can affect the rate of tooth movement. Preliminary data showed
that the rate of tooth movement may be affected by variables such as age, sex, as well as
alveolar bone levels, tooth root length and alveolar bone quality. The purpose of this study
is to examine the amount of tooth movement achieved over time between subjects undergoing
aligner treatment using a pulsation device known as AcceleDent® Aura with those not using
the device.

A preliminary validation pilot study will be done to calibrate all staff on study
procedures. The pilot will consist of 3 subjects using the active AcceleDent® Aura device
and 3 using the sham control AcceleDent® Aura device for 4 weeks. Study staff will be
calibrated for all study procedures.

The primary study will be a prospective, single-center, randomized crossover clinical trial
comparing two groups of subjects with 40 participants. Subjects will be randomized to groups
that will receive aligner treatment while using either an active AcceleDent® Aura device or
a sham control AcceleDent® Aura device for the first 6 weeks of the study. After 6 weeks,
groups will cross-over and switch devices, and tooth movement will be followed for another 6
weeks. Patients will be blinded as to which device they are using. Amount of tooth movement
per week, pain perception, and change in gingival crevicular fluid biomarkers will be
outcomes assessed. Device safety evaluation to be performed will include adverse events and
clinical examination findings including pulp vitality testing and periodontal probe results.

Inclusion Criteria:

- Males or females between and including the ages of 18 and 40 yo desiring orthodontic
treatment that could be completed within two years of treatment with either fixed
appliances or aligner treatment. Subjects may have had previous orthodontic
procedures.

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

- At least one upper maxillary central incisor that is positioned to allow
anterio-posterior (AP) movement (crown tipping only) of 1.98 mm.

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

- Good health as determined by medical history.

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

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

Exclusion Criteria:

- Severe malocclusions that would take longer than 2 years of treatment or require
surgical intervention.

- Significant periodontal disease (> 3mm pocket depth or >1 mm of recession on upper
anterior teeth).

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

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

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

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

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

- Any condition or use of medication which in the opinion of the investigator
interferes with the biology of tooth movement.

- Any condition which in the opinion of the investigator results in increased risk to
the subject.