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

Not Applicable

• Conditions: Malocclusion
• Interventions: Procedure: Conventional Orthodontic Treatment; Procedure: Motion View

• Registration Number: NCT02221856
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-21
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Study Start: 2017-02-08
• Last Update Posted: 2017-02-09
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Orthodontic Treatment	Conventional Orthodontic Treatment	-
Motion View	Motion View	-

Primary Outcome Measures

Name	Time	Method
Discrepancy between predicated and actual tooth positions	up to 12 months

Secondary Outcome Measures

Name	Time	Method
assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system	up to 12 months

Trial Locations

Locations (1)

Harvard School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States