Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2015-05-31
2017-12-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar
NCT05801328
Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures
NCT07153120
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
NCT01876979
3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation
NCT06978530
Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .
NCT02960048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hybrid
Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Stryker Hybrid
Place Hybrid arch bars
Erich
Placement of Erich archbars for open or closed reduction of mandible fractures
Erich
Control group is Erich arch bars
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stryker Hybrid
Place Hybrid arch bars
Erich
Control group is Erich arch bars
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Infected fractures
3. Previously treated fractures
4. Complete edentulism
5. Gun shot wounds
6. Pregnancy or breast feeding
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grady Memorial Hospital
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00076048
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.