Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures
Primary Purpose
Mandible Fracture, Rigid Internal Fixation, Three-dimensional Finite Element
Status
Approved for marketing
Phase
Locations
China
Study Type
Expanded Access
Intervention
Biodegradable and titanium fixation used in mandibular fractures.
Sponsored by
About this trial
This is an expanded access trial for Mandible Fracture
Eligibility Criteria
Inclusion Criteria:
- Undisplaced and displaced mandibular symphysis and parasymphysis solitary fractures conducted at the department of Oral and Maxillofacial (OMF) Surgery, Tianjin Medical University General Hospital
Exclusion Criteria:
- The exclusion criteria were comminuted fractures
- Diabetes
- Connective tissue diseases
- Patients under the age of 18 and over the age of 60
Sites / Locations
- Tianjin Medical University General Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02181868
Brief Title
Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Approved for marketing
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louqiang Zhang
4. Oversight
5. Study Description
Brief Summary
The mandible bears a wide range of mechanical load from the contraction of masticatory muscles, and has a significant function in normal chewing movements. Mandibular fractures are the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults, road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in the reported percentage of anterior mandible fractures, aggregate analysis approximates these fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has become a common treatment for mandibular fractures, in which titanium plates are used in the operation. Some patients have to remove the titanium plates in a second operation following bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws have been developed to eliminate the problems associated with titanium fixtures. In this study, we aim to compare the clinical performance between biodegradable and titanium fixation systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis solitary fractures. We also investigate the stress distributions of biodegradable and titanium fixation systems at mandibular symphysis solitary fracture on the conditions of intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite element analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible Fracture, Rigid Internal Fixation, Three-dimensional Finite Element
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Biodegradable and titanium fixation used in mandibular fractures.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
Undisplaced and displaced mandibular symphysis and parasymphysis solitary fractures conducted at the department of Oral and Maxillofacial (OMF) Surgery, Tianjin Medical University General Hospital
Exclusion Criteria:
The exclusion criteria were comminuted fractures
Diabetes
Connective tissue diseases
Patients under the age of 18 and over the age of 60
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
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Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures
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