Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
Phase: NA
Conditions: Dental Malocclusion
Sponsor: LightForce Orthodontics

Precision Orthodontics: A Comparison of Custom vs Traditional
Bracket Treatment Efficiency
NCT Number: NCT04266769
December 17, 2019

LightForce Orthodontics, Inc
Proposed Investigational Testing
Precision Orthodontics: A Comparison of Custom vs Traditional
Bracket Treatment Efficiency
Scope
LightForce Orthodontics' (LFO) investigational testing aims to target multiple investigations sites
to examine treatment efficiency metrics using a completely digital and patient-specific bracket
treatment system for the correction of malocclusions.
Hypothesis
A fully digital and custom treatment system will provide a more efficient treatment
experience compared to standard bracket treatments within the associated
orthodontist's experience.
Objective
Compare metrics of treatment efficiency from a traditional "one-size fits all" fixed
appliance (FA) system to a fully digital and 3D printed FA system.
Proposed Testing
Significance
Standard orthodontic practices use injection molded stock (not custom; traditional) brackets based
on pre-programmed prescriptions to treat all patients with a variety of malocclusions. As each
patient's anatomy and malocclusion are unique, this one size fits all approach leads to multiple
forms of inefficiencies within a treatment. LightForce Orthodontics offers a digital treatment
planning platform and patient-specific 3D printed polycrystalline alumina brackets which combat
these inefficiencies and provide a better treatment plan.
The proposed LFO technology receives a digital scan of the patient's anatomy into the treatment
planning software where the teeth are digitally moved from their starting position to the desired
finishing positions. Brackets are placed in locations which enable Andrews' Straight Wire Appliance
(SWA) principles to obtain the final occlusion. Among others, SWA principles dictate that a

treatment is completed when the arch wire no longer has any bends to it. The software program
then reconstructs the initial malocclusion with the brackets in the locations which provide the
desired outcome. Thus, the orthodontist can begin a treatment knowing exactly where the teeth
will end up.
Even with this digital system, a stock bracket would not be able to precisely move the teeth to the
desired position. This is due to the aforementioned morphology difference between patients and
the inability of a one size fits all bracket to accommodate. The differences between the stock bracket
base structure and the tooth surface must be manually filled in with an inexact amount of bonding
material yielding inexact positioning which may create unintended movement directions. While the
LFO brackets have a similar facial profile to stock brackets, which facilitate standard methods of
care, the bracket's base is contoured to match the patient's corresponding tooth morphology. This
means that the exact angles of torque, tip, and angulation, which facilitate orthodontic movement,
are built into each bracket creating a predictable solution.
In a current standard of care example, the torque of a stock bracket may not be enough to move a
tooth into the appropriate finishing angle. In this case, the orthodontist must then bend the arch
wire to a certain degree to compound this torque - also known as a third order orthodontic bend.
The resulting force is then sufficient to move the tooth to the correct angle. This action may need to
be applied to multiple teeth throughout treatment. When a wire bend occurs multiple weeks are
added to the desired finishing appointment as the orthodontist must allow the tooth to move and
then evaluate the change. Due to the LFO contoured base as well as the SWA principles employed in
the LFO System planning process, there should be no need for wire bends during treatment.
Historically, stock brackets must also be placed directly onto the tooth. This can lead to imperfect
positioning even by the most experienced orthodontists. This imperfect positioning can either be
caused by human-error during placement or because the orthodontist can not anticipate the exact
bracket placement that will lead to a perfect finishing occlusion. During treatment the orthodontist
must debond the imperfectly placed bracket in favor of a new bracket placed with the same level
of insufficient precision. Each replacement extends the finishing appointment date.
This practice of direct bonding could yield inaccurate placement of even perfectly positioned and
contoured brackets created using a digital treatment program. To solve this issue, LFO created a
3D printed patient-specific indirect-bonding (IDB) system. Designed directly from the desired
bracket placement on the teeth in malocclusion, like a digital mold, the IDB tray precisely matches
the tooth anatomy and brackets. Once printed, the corresponding patient's brackets are placed in
the IDB tray's bracket wells. The orthodontist can paste the bonding material onto the brackets,
while remaining in their specific wells, then place the IDB trays in the patient's mouth and bond the
brackets. Once the tray is removed the brackets remain on the teeth in the exact position they
were designed for in the treatment planning system.
The presented investigational testing aims to assess treatment efficiency metrics using the
LightForce Orthodontic system on a variety of malocclusions across multiple sites compared to the
investigator's past experience using traditional bracket systems.

Investigation Design & Participants
This multi-site investigation will evaluate treatment efficiency metrics of different orthodontists
using the same LightForce Orthodontic digital treatment planning system and patient-specific
brackets. Data collection will include treatment efficiency metrics, participant data such as (but not
limited to) gender, age and medical history, and experiential data of standard bracket treatment
efficiency metrics. Efficiency metrics may include:
●
Treatment length
●
Bonding/De-bonding appointment time length
●
Length of time to achieve leveling and alignment
●
Number of unscheduled appointment
●
Number of debonded brackets
●
Number of repositioned brackets
All patients that visit the investigation sites are evaluated during initial consultations for their
particular medical needs and orthodontic treatment. If a patient is eligible for the investigation,
they will be presented with the treatment plan, asked whether they would like to participate, and
given a consent form to sign.
There are no specific recruitment materials for this study. However, each orthodontist is provided
with a LightForce Orthodontics welcome kit before they enroll their first patient. This includes a
typodont, a sample product package (box, brackets in trays and arch form) and patient brochures
as pictured below. The patient brochures are not included as study recruitment material.
To run statistical analysis, at least 22 patients must participate at each investigation site to have a
power of 90% at a 5% significance level. No patients will be withdrawn from the investigation
unless the investigator or patient chooses to discontinue treatment. If there is a lack of compliance
with the investigator's treatment plan and/or a developing health condition during treatment, the
patient's data may be considered an outlier and not used in statistical analysis.
Inclusion Criteria

●
All subjects must be healthy and between the ages of 10 and 65.
●
Eruption of all permanent teeth excluding second and third molars
●
Sufficient labial tooth surface for bonding
●
No more than one tooth missing from a single arch quadrant
●
No existing molar tubes or bands
Exclusion Criteria
●
Presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes
affecting bone or teeth, impacted teeth (excluding 3rd molars), and tumors of the
parathyroid gland Presence of bridges or implants
●
Cases requiring orthognathic surgery
●
Significant periodontal disease
●
Intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal
Anti Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class)
Pregnancy
Clinical Process
Orthodontic treatment process through out this investigation will follow standardized
practices. Treatment data will be acquired throughout the following process:
●
Facial photos and intra-oral scans will be taken of the patient's teeth
●
Treatment will be planned using the LightForce Orthodontics' LF Pro treatment planning
system
●
LightForce Orthodontics will manufacture and ship the patient-specific brackets to the
investigator
●
Standard Orthodontic Treatment Progressions
○
Brackets will be bonded to patient’s teeth
○
Follow up appointments to change ligatures, move through standard wire
progression, and/or replace brackets. The number of appointments can vary based on
the patient’s treatment plan and progress.
○
Brackets are removed
Conflicts of Interest
The LightForce Orthodontic braces are commercially available in the United States. Every
orthodontist in this study will pay LightForce Orthodontics for the LFO System as they would if
they were available to purchase in Canada. As such there is no conflict of interest.
However, some investigators are a part of the LightForce Orthodontics' clinical executive board
(CEB). If so a CEB Appendix is attached to their patient's consent form. To also combat any undue
influence conflict of interests may have on this study, the investigators chosen are a mix of CEB and
non-CEB members. This means any CEB member's data should not influence the overall study

results.
Statistical Analysis
Statistical tests (Student's t-test) will be run to make sure LightForce Orthodontics's Clinical Executive
Board (CEB) member treatment group outcomes are not statistically different from non-CEB
members within this study. If they are, the data collected from that investigation site will be
removed.
We will assume the data will be normally distributed for this study. The primary outcome measures
are impacted directly by the patient's age and by the treating orthodontists. Thus the outcome
variables will be analyzed through analysis of covariance (ANCOVA) tests controlling for age and
orthodontist. Multiple pair wise comparisons may be conducted (t-tests) to determine significant
differences between groups. Bonferroni corrections may be conducted to prevent the introduction
of Type 1 errors. Multivariate linear regressions may also be used to examine differences in the
treatment groups. All statistical tests will be two-sided with a p-value of 0.05 for statistical
significance. All statistical analyses will be conducted in a statical software such as SAS software (SAS
Institute, Cary, NC).
Risk Assessment
There are no additional risks to participating in this study outside of the standard risks associated
with orthodontic treatment. The study does not change the standard method of diagnosis and care
for the treatment of malocclusion. The LFO bracket system has been approved by the FDA and is
comparable to existing bracket systems. During the approval process, the device underwent
standard orthodontic bracket performance tests compared to commercially available devices and
biocompatibility tests. These reports can be made available upon request.
Each system is shipped with an instructions for use which contains the following precautions -
there are no known adverse reactions or contraindications for this device:
●
Due to the hardness of ceramic brackets, bonding brackets in occlusion should be
avoided to prevent wearing of enamel surfaces during all phases of treatment.
●
LightForce Orthodontic Brackets can withstand all normal torque requirements. However,
care should be taken when making torquing activations. Large corrections with full size
stainless steel wires may result in bracket failure and should be avoided.
●
Instruct not to chew or bite hard substances such as hard candy, ice, or carrots. Careful
and thorough patient instruction is key to avoiding appliance or enamel damage.
●
LightForce Orthodontic Ceramic Brackets should be avoided in bonding to dental
porcelain, restorative or compromised (i.e. large restorations, peg laterals, or pre-existing
pathological conditions) enamel surfaces.
●
Bonding to porcelain crowns or facings may cause chipping or breakage of the crown or
facing during treatment or debonding.

●
LightForce Orthodontic Ceramic Brackets are for single patient use only.
Data Monitoring and HIPAA Privacy Protections
All data taken during this study is apart of normal data acquisition for an orthodontic treatment.
Each patient will be given a patient alias number. The LFO treatment representative will see
identifying information regarding patients but will only record the patient's alias and relevant
information for the study. The data collected will not directly link back to the participant's identity
which minimizes the risk of a confidentiality breach. Experiential data will be acquired by LFO via
communication with the orthodontist. All information is kept on password protected computers
and servers. No paper print outs are kept in this study. The signed consent forms are scanned and
sent back to LFO through secure emails. The orthodontist can then shred the forms. All personnel
involved in this study as well as all members of LightForce Orthodontics are trained on Health
Insurance Portability and Accountability Act (HIPAA) privacy rules. The investigators have all been
trained on human subjects' research.
The LFO investigators will be responsible for process the data, ensuring the data is de-identified,
and confidentiality is maintained. They will also be responsible for internal checks and project
oversight. Data will be kept for a minimum of 4 years but up to 7 years after the study completion
then destroyed.
Reportable Events
All reportable events will be documented by the treating orthodontist and relayed to the research
team at LightForce Orthodontics within 72 hours. LFO will then inform all regulatory bodies
deemed necessary within the said time frame.
This mandatory problem reporting includes cases in which the incident:
1. is related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its
labelling or in its directions for use, and
2. has led to the death or a serious deterioration in the state of health of a patient, user or other
person, or could do so were it to recur
Reports will be completed within timeframes set (10 or 30 days) within the Investigational Testing
Guidance. If a participant feels the need to report any events, contact information is also provided
in the consent forms.
Patient Assent/Consent
This investigation provides three types of informed consent forms. For patients under the age of 16
in Canada (18 in Quebec) a child's assent form must be signed as well as a parent/guardian's

consent for child's recruitment. A child may chose to not participate and not sign the assent form
even if a parent or guardian has signed the recruitment consent. For patients over the age of 16 (18
in Quebec) a patient consent form is also provided.
All assent/consent forms are provided in English and French and maintained by LightForce
Orthodontics. The investigator will scan the consent/assent form and send it to LFO after
consent has been given. The investigator will provide the patient and/or guardian with a copy of
their assent/consent form. The signed form will be kept in the Informed Consent folder at
LightForce Orthodontics.