Clinical Trial Comparing the Accuracy of Computer-assisted Orthodontic Treatment Modalities



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:Any - 50
Updated:4/21/2016
Start Date:June 2014
Contact:Mohamed Masoud, BDS, DMSc
Email:Mohamed_Masoud@hsdm.harvard.edu
Phone:617-432-4281

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A Prospective Clinical Trial Comparing Three Computer Aided Design Systems (SureSmile, Insignia, Invisalign) to Conventional Orthodontic Appliances

Technological advances have made computer aided orthodontic treatment planning possible. 3D
dental scanners and software make it possible to design and approve the outcome before
treatment begins. Manufacturers have provided different customized appliance systems that
would help practitioners achieve those computer-designed outcomes. The purpose of this study
is to determine the accuracy of three custom appliance systems (SureSmile, Insignia, or
Invisalign) at achieving the predicted outcomes and comparing that to the accuracy of
conventional orthodontic treatment at achieving a predetermined goal. The results of this
study will help orthodontists and patients know if there is an advantage to using custom
appliances and if one custom system is superior at achieving certain movements than the
other. The study will be a prospective clinical study and will include a total of 240 arches
from 120 patients enrolled in private practices. 30 patients will be assigned to each of the
four study groups (SureSmile, Insignia, Invisalign, or control). All four groups will have a
3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated
design that the orthodontist believes is the optimized outcome. At the end of each patient's
participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and
alignment using ABO's objective grading system's criteria for alignment, marginal ridges and
buccolingual inclination. Each arch will then be superimposed on the predicted outcome to
determine how accurate each system was at achieving the planned movements in all 3
dimensions. We hypothesize that the accuracy of three custom appliance systems (SureSmile,
Insignia, or Invisalign) at achieving the predicted outcomes will differ in comparison to
the accuracy of conventional orthodontic treatment at achieving a predetermined goal.


Inclusion Criteria:

- Healthy subjects seeking orthodontic care

- All permanent teeth must be erupted, excluding second and third molars

- Non-extraction cases

- No more than 7 mm crowding

- No more than 45 degrees of rotations

Exclusion Criteria:

- Presence of systemic disease

- Craniofacial anomalies, including cleft lip and palate

- Syndromes affecting bone or teeth

- Congenitally missing teeth, excluding third molars

- Presence of bridges or implants

- Periodontal disease

- Use of drugs affecting tooth movement or bone metabolism (NSAIDS, bisphosphonates,
PTH, corticosteroids)

- Pregnancy

- Severe crowding or dental protrusion requiring extractions
We found this trial at
3
sites
Boston, Massachusetts 02115
Principal Investigator: Mohamed Masoud, BDS, DMSc
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Lancaster, Pennsylvania 17601
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Lexington, Massachusetts 02421
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Lexington, MA
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