Clinical trial NCT02221856: A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement
Official title: A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Keywords: Conventional orthodontic treatment
Motion View
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 30
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 computer-guided indirect bonding of orthodontic brackets at achieving the predicted alignment and comparing that to the accuracy of conventional orthodontic bracket placement 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. The study will be a prospective clinical study and will include a total of 60 arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will be assigned to each of the two study groups (Motion View or control). Both 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 computer-guided indirect bonding (Motion View) at achieving the predicted outcomes will differ in comparison to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects seeking orthodontic care
* All permanent teeth must be erupted, excluding second and third molars
* Class I, II, and III 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

Primary outcomes:
measure: Discrepancy between predicated and actual tooth positions
timeFrame: up to 12 months
Secondary outcomes:
measure: assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Medicine
name: Mohamed Masoud, BDS, DMSc
role: PRINCIPAL_INVESTIGATOR
References: