CClinicalTrials.gg
Status unknownNCT02221856Updated Feb 9, 2017

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

An interventional study of Motion View and Conventional Orthodontic Treatment in Malocclusion, sponsored by Harvard School of Dental Medicine. Status unknown at 1 site in United States. Open to participants aged Up to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Harvard School of Dental Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
Up to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malocclusion

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Keywords

  • Conventional orthodontic treatment
  • Motion View
03

Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Motion View

    Procedure: Motion View

  • Active comparator
    Conventional Orthodontic Treatment

    Procedure: Conventional Orthodontic Treatment

Interventions

  • ProcedureMotion 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.

  • ProcedureConventional Orthodontic Treatment

    orthodontic treatment using non-customized brackets and stock wires

05

What researchers measure

Primary outcomes

  1. Discrepancy between predicated and actual tooth positions

    Time frame: up to 12 months

Secondary outcomes

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

    Time frame: up to 12 months

06

Study locations

1 of 1 sites recruiting
  • Harvard School of Dental Medicine
    Boston, Massachusetts 02115, United States
    • Mohamed Masoud · Contact
    • Mohamed Masoud, BDS, DMSc · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT02221856
Lead sponsor
Harvard School of Dental Medicine
Responsible party
Mohamed Masoud (Principal Investigator, Harvard School of Dental Medicine) — Principal investigator
First posted
Aug 21, 2014
Start date
Feb 8, 2017
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Feb 9, 2017

Study contacts

Mohamed Masoud, BDS, DMSc
Contact
Mohamed_Masoud@hsdm.harvard.edu
617-432-4281
Mohamed Masoud, BDS, DMSc
principal investigator · Harvard School of Dental Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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