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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid | Experimental | Placement of Hybrid arch bars for open or closed reduction of mandible fractures |
|
| Erich | Active Comparator | Placement of Erich archbars for open or closed reduction of mandible fractures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker Hybrid | Device | Place Hybrid arch bars |
| |
| Erich |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Place Archbars | Time taken to place archbars | During initial admission and surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fracture Healing at 6 Weeks | Radiographic healing | 6 weeks |
| Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid | Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars |
| FG001 | Erich | Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid | Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars |
| BG001 | Erich | Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Place Archbars | Time taken to place archbars | Posted | Mean | Standard Deviation | minutes | During initial admission and surgery |
|
|
6 weeks post baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hybrid | Placement of Hybrid arch bars for open or closed reduction of mandible fractures Stryker Hybrid: Place Hybrid arch bars |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Francis Bouloux | Emory University | 404-778-4500 | gfboulo@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2015 | Nov 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2018 | Jan 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| Device |
Control group is Erich arch bars |
|
assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures
| up to 6 weeks post operatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Fracture Healing at 6 Weeks | Radiographic healing | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures | assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures | Posted | Count of Participants | Participants | up to 6 weeks post operatively |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Erich | Placement of Erich archbars for open or closed reduction of mandible fractures Erich: Control group is Erich arch bars | 0 | 24 | 0 | 24 | 0 | 24 |
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| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |