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

NCT ID: NCT02221856

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-08

Study Completion Date

2018-05-31

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.

Detailed Description

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Conditions

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Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Motion View

Group Type EXPERIMENTAL

Motion View

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Conventional Orthodontic Treatment

Intervention Type PROCEDURE

orthodontic treatment using non-customized brackets and stock wires

Interventions

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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.

Intervention Type PROCEDURE

Conventional Orthodontic Treatment

orthodontic treatment using non-customized brackets and stock wires

Intervention Type PROCEDURE

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
Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard School of Dental Medicine

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Masoud

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Masoud, BDS, DMSc

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Dental Medicine

Locations

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Harvard School of Dental Medicine

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mohamed Masoud, BDS, DMSc

Role: CONTACT

617-432-4281

Facility Contacts

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Mohamed Masoud

Role: primary

Other Identifiers

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Masoud-001

Identifier Type: -

Identifier Source: org_study_id

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