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A Comparison of Stryker Hybrid Arch Bars

Emory University logo

Emory University

Status

Completed

Conditions

Fracture Mandible

Treatments

Device: Erich
Device: Stryker Hybrid

Study type

Interventional

Funder types

Other

Identifiers

NCT02283528
IRB00076048

Details and patient eligibility

About

Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).

The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
  2. Age 18 years - 90 years
  3. Ability to give informed consent
  4. Minimum 6 weeks follow-up
  5. Pre and post-operative panoramic xrays

Exclusion criteria

  1. Comminuted fractures
  2. Infected fractures
  3. Previously treated fractures
  4. Complete edentulism
  5. Gun shot wounds
  6. Pregnancy or breast feeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Hybrid
Experimental group
Description:
Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Treatment:
Device: Stryker Hybrid
Erich
Active Comparator group
Description:
Placement of Erich archbars for open or closed reduction of mandible fractures
Treatment:
Device: Erich

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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