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

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ClinicalTrials.gov Identifier: NCT02221856
Recruitment Status : Unknown
Verified February 2017 by Mohamed Masoud, Harvard School of Dental Medicine.
Recruitment status was:  Recruiting
First Posted : August 21, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Masoud, Harvard School of Dental Medicine

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.

Condition or disease Intervention/treatment Phase
Malocclusion Procedure: Motion View Procedure: Conventional Orthodontic Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Experimental: Motion View Procedure: Motion View
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.

Active Comparator: Conventional Orthodontic Treatment Procedure: Conventional Orthodontic Treatment
orthodontic treatment using non-customized brackets and stock wires




Primary Outcome Measures :
  1. Discrepancy between predicated and actual tooth positions [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221856


Contacts
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Contact: Mohamed Masoud, BDS, DMSc 617-432-4281 Mohamed_Masoud@hsdm.harvard.edu

Locations
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United States, Massachusetts
Harvard School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mohamed Masoud         
Principal Investigator: Mohamed Masoud, BDS, DMSc         
Sponsors and Collaborators
Harvard School of Dental Medicine
Investigators
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Principal Investigator: Mohamed Masoud, BDS, DMSc Harvard School of Dental Medicine
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Responsible Party: Mohamed Masoud, Principal Investigator, Harvard School of Dental Medicine
ClinicalTrials.gov Identifier: NCT02221856    
Other Study ID Numbers: Masoud-001
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Keywords provided by Mohamed Masoud, Harvard School of Dental Medicine:
Conventional orthodontic treatment
Motion View
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases