A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement
Primary Purpose
Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motion View
Conventional Orthodontic Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Conventional orthodontic treatment, Motion View
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
Sites / Locations
- Harvard School of Dental MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motion View
Conventional Orthodontic Treatment
Arm Description
Outcomes
Primary Outcome Measures
Discrepancy between predicated and actual tooth positions
Secondary Outcome Measures
assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system
Full Information
NCT ID
NCT02221856
First Posted
August 15, 2014
Last Updated
February 7, 2017
Sponsor
Harvard School of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02221856
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Dental Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Conventional orthodontic treatment, Motion View
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motion View
Arm Type
Experimental
Arm Title
Conventional Orthodontic Treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Motion View
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Orthodontic Treatment
Intervention Description
orthodontic treatment using non-customized brackets and stock wires
Primary Outcome Measure Information:
Title
Discrepancy between predicated and actual tooth positions
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system
Time Frame
up to 12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Masoud, BDS, DMSc
Phone
617-432-4281
Email
Mohamed_Masoud@hsdm.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Masoud, BDS, DMSc
Organizational Affiliation
Harvard School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Masoud
First Name & Middle Initial & Last Name & Degree
Mohamed Masoud, BDS, DMSc
12. IPD Sharing Statement
Learn more about this trial
A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement
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