Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
NCT ID: NCT01876979
Last Updated: 2017-06-28
Study Results
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View full resultsBasic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2013-07-31
2015-04-30
Brief Summary
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Detailed Description
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To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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IMF Screws
Use of IMF screws as a means to wire the jaws.
IMF Screws
stainless steel screws placed in bone
Erich Arch Bars
Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars
Surgical braces wired around teeth
Interventions
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IMF Screws
stainless steel screws placed in bone
Erich Arch Bars
Surgical braces wired around teeth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with no greater than one (1) open fracture of the tooth-bearing mandible
* Mandibular angle fractures ± Ramus or subcondylar fracture
* Body/symphysis ± subcondylar
* Isolated angle fracture
* Isolate subcondylar fractures
* Bilateral subcondylar fractures
* Any condylar head/neck fracture requiring treatment
* Patients who are candidates for treatment of their fractures in the operating room setting
Exclusion Criteria
* Patients with developing tooth buds anterior to the second molars
* Patients with inadequate stability of occlusion
* Edentulism
* Unstable vertical and horizontal stops to the occlusion
* Patients with disorders affecting bone healing, metabolism and turnover
* Those patients on bisphosphonates, oral or IV
* Patients with evidence of intrabony pathology of the mandible or maxilla
* The presence of any of the following:
* Greater than one (1) open fracture of the tooth-bearing mandible
* Bilateral angle fractures are exempt from this
* Comminuted fractures of the mandible
* Concomitant infection, or osteomyelitis of the mandible
* Mechanism of injury
* Pathologic fracture
* Gun-shot wounds
18 Years
70 Years
ALL
No
Sponsors
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Christiana Care Health Services
OTHER
Responsible Party
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Daniel Meara
Oral and Maxillofacial Surgery Resident
Principal Investigators
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Daniel Meara, MD
Role: PRINCIPAL_INVESTIGATOR
Christiana Care Health Services
Daniel J Meara, MS, MD, DMD
Role: STUDY_CHAIR
Christiana Care Health Services
Locations
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Christiana Care Hospital
Newark, Delaware, United States
Wilmington Hospital
Wilmington, Delaware, United States
Countries
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Other Identifiers
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DDD# 602252
Identifier Type: OTHER
Identifier Source: secondary_id
CCC# 33082
Identifier Type: -
Identifier Source: org_study_id
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