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Completed
NCT07590401
Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures
Conditions: Mandibular Fracture
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 22
Sponsor: Alexandria University
Location: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt Alexandria Azarita
Summary
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.
Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
Eligibility Criteria
Inclusion Criteria:
* Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
* Adult patients with no gender predilection who agreed to present for follow-up visits
* A fracture that demands open reduction and internal fixation.
* The patient is medically fit for general anesthesia
Exclusion Criteria:
* ASA classification IV, V, VI
* Existence of infection at the fracture line
* Pathological fracture
* An old fracture
* Completely edentulous patient
* Patients with a comminuted fracture
Source: ClinicalTrials.gov (NCT07590401). StuddyBuddy aggregates publicly available trial information.