A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement

Conditions
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Malocclusion

Intervention / Treatment
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* Procedure: Motion View
* Procedure: Conventional Orthodontic Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motion View<br> | Procedure: Motion View<br>* Motion View, a software we are using to place brackets virtually on a 3D rendition of a patients teeth, will be used to indirectly bond brackets onto patient's teeth with a 3D printed plastic transfer JIG in which the brackets will be precisely placed on the patients teeth according to the computer-guided software.<br>|
| Active Comparator: Conventional Orthodontic Treatment<br> | Procedure: Conventional Orthodontic Treatment<br>* orthodontic treatment using non-customized brackets and stock wires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discrepancy between predicated and actual tooth positions |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conventional orthodontic treatment, Motion View