A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Launched by AO CLINICAL INVESTIGATION AND PUBLISHING DOCUMENTATION · Jan 14, 2015
Trial Information
Current as of August 15, 2025
Completed
Keywords
ClinConnect Summary
Prospective data will be collected in 314 patients suffering from bilateral (double) mandibular fracture randomly treated either with non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side. This is a study where patients will be treated per randomization to one of the two established treatments and followed for further clinical examination post-operatively at 6 weeks and 3 months after the intervention.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age 18 years or older at the date of the surgery
- * Diagnosis of bilateral (double) mandibular fracture located in:
- • Angle and body or
- • Angle and symphysis or
- • Body and symphysis
- • Dentition: Patients must have most of their maxillary and mandibular teeth present and it must be possible to identify proper occlusion. The application of intraoperative Mandibulo-maxillary fixation (MMF) using arch bars must be possible
- • Ability to understand the content of the patient information / Informed Consent Form
- • Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- • Signed and dated IRB/EC-approved written informed consent
- Exclusion Criteria:
- • Fractures displaying continuity defect or comminution
- • Fractures showing clinical signs of infection at presentation
- • Edentulous mandible fracture
- • Fractures requiring an extra-oral surgical approach
- • Concomitant maxillary fractures
- • Concomitant condylar fracture
- • Prior surgical treatment of the mandibular fracture(s)
- • Atrophy of the mandible (\<20 mm vertical height) at the level of the fracture(s)
- • Polytrauma (i.e. severe injuries leading to life-threatening condition)
- • Prisoners
- • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
About Ao Clinical Investigation And Publishing Documentation
AO Clinical Investigation and Publishing Documentation is a leading organization dedicated to advancing medical research through the rigorous evaluation of clinical trials. Specializing in the design, implementation, and dissemination of clinical studies, AO focuses on enhancing patient outcomes and contributing to the body of scientific knowledge. With a commitment to ethical standards and regulatory compliance, the organization collaborates with healthcare professionals and institutions to ensure high-quality data collection and analysis. Their expertise in publishing ensures that findings are effectively communicated to the medical community, fostering innovation and informed decision-making in patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Doha, , Qatar
Hamburg, , Germany
Helsinki, , Finland
New York, New York, United States
Durban, , South Africa
San Antonio, Texas, United States
München, , Germany
Sungai Buloh, , Malaysia
Constanta, , Romania
Madrid, , Spain
Lviv, , Ukraine
Patients applied
Trial Officials
Risto Kontio, MD DDS PhD
Principal Investigator
Helsinki University Central Hospital
Edward Ellis III, DDS MS
Principal Investigator
UT Health Science Center at San Antonio
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials