Clinical Trial

Radiographic and Clinical Evaluation of Three-Dimensional Delta Plate in Internal Fixation of Mandibular Sub-condylar Fractures.

Completed
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Summary
In this study, we intend to examine the efficacy of 3D delta plates through radiographic evaluation of anatomic reduction and vertical ramus height as the main outcome and clinical assessment of pain and range of mandibular movements as secondary outcomes. This Single arm longtudinal study will include 14 cases of trauma having mandibular sub condylar fractures, in which open reduction and internal fixation are indicated. After selecting patients according to the inclusion criteria, all patients will undergo open reduction and rigid fixation. Fracture will be stabilized using 4 hole, 2.0 mm 3-D Delta titanium plates using pre-auricular or retromandibular incision. Radiographic evaluation using Computed Topograhy (CT) scans will be carried on immediatly after the operation then 3 months post operatively. While, Clinical assessment will be performed at the following intervals after the surgery( 1 week, 1 month, 3 months)
Trial Details
NCT Number NCT07311239
Lead Sponsor Ain Shams University
Collaborators: Ahmed Maher Teaching Hospital
Conditions Mandible Fracture
Enrollment 14 participants
Start Date 2024-11-11
Primary Completion 2025-07-19 (estimated)
Study Completion 2025-10-20 (estimated)
Updated on ClinicalTrials.gov 2025-12-30