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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02221856
• Other study ID #: Masoud-001
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2014
• Last updated: February 7, 2017
• Start date: February 8, 2017
• Est. completion date: May 2018

Study information

• Verified date: February 2017
• Source: Harvard School of Dental Medicine
• Contact: Mohamed Masoud, BDS, DMSc
• Phone: 617-432-4281
• Email: Mohamed_Masoud[@]hsdm.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

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.
• Conventional Orthodontic Treatment
orthodontic treatment using non-customized brackets and stock wires

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Dental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrepancy between predicated and actual tooth positions		up to 12 months
Secondary	assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system		up to 12 months