NCT02221856

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

August 15, 2014

Last Update Submit

February 7, 2017

Conditions

Malocclusion

Keywords

Conventional orthodontic treatmentMotion View

Outcome Measures

Primary Outcomes (1)

  • Discrepancy between predicated and actual tooth positions

    up to 12 months

Secondary Outcomes (1)

  • assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system

    up to 12 months

Study Arms (2)

Motion View

EXPERIMENTAL
Procedure: Motion View

Conventional Orthodontic Treatment

ACTIVE COMPARATOR
Procedure: Conventional Orthodontic Treatment

Interventions

Motion ViewPROCEDURE

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.

Motion View
Conventional Orthodontic TreatmentPROCEDURE

orthodontic treatment using non-customized brackets and stock wires

Conventional Orthodontic Treatment

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed Masoud, BDS, DMSc

    Harvard School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Masoud, BDS, DMSc

CONTACT

617-432-4281Mohamed_Masoud@hsdm.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 21, 2014

Study Start

February 8, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

US(1)