Anterior Mandibular Fracture
Conditions
Keywords
Additive, Subtractive, Custom-Made Plates, Interforaminal, Mandibular, Fractures
Brief summary
This study aims to compare the mechanical properties, including tensile strength, shear strength, and flexural strength, as well as the clinical outcomes of additive and subtractive manufacturing techniques used to fabricate custom-made plates for the fixation of interforaminal mandibular fractures. A total of 16 patients were included and allocated into two groups: one treated using plates fabricated with the additive manufacturing technique and the other with the subtractive manufacturing technique. Mechanical performance was evaluated using standardized biomechanical testing, while clinical outcomes were assessed during scheduled postoperative follow-up visits. The objective of the study is to determine which fixation approach provides superior biomechanical performance and favorable clinical healing outcomes.
Detailed description
This randomized clinical study included 18 patients who were assessed for eligibility. Two patients were excluded-one did not meet the inclusion criteria and another declined participation-leaving a final sample of 16 patients who were randomly allocated into two equal groups (n=8 per group). All included patients were followed throughout the entire study period, and none were lost to follow-up. Both study groups demonstrated comparable baseline characteristics with no statistically significant differences regarding age, sex distribution, trauma side, cause of injury, type of fracture, and operative time. All surgical procedures were performed using standardized operative protocols, and postoperative evaluations were conducted at fixed intervals. Clinical outcomes included wound healing status, postoperative edema, infection, and wound dehiscence. Functional performance was evaluated through maximum mouth opening measurements and patient-reported outcomes involving occlusion and self-chewing ability. Radiographic and mechanical assessments were also performed, including tensile strength, shear strength, and flexural bending tests for the fixation systems used in each group. Across the follow-up period, both groups showed satisfactory wound healing, absence of infection or dehiscence, progressive improvement in mouth opening, and gradual restoration of occlusal stability and chewing function, with no significant intergroup differences in clinical parameters. Mechanical testing demonstrated significant differences between the two fixation systems. All collected data were statistically analyzed, and outcomes were reported in accordance with CONSORT guidelines.
Interventions
DEVICEadditive plating group
Additive manufacturing is the process of creating parts by joining materials based on 3D model data, typically layer by layer, in contrast to subtractive and formative manufacturing methods. While most of the global activity in additive manufacturing currently involves polymer-based systems, there has been increasing interest and activity in fabricating metallic parts
DEVICEsubtractive plating group
In CNC machining, cutting tool removes material to achieve the desired geometry. The process involves using CAD to create the model to be machined and CAM to provide instructions to the CNC machine on how to remove the material. There are three major machining processes for material removal based on 3D models: turning, drilling, and milling. Additional subtractive manufacturing techniques, such as laser cutting, waterjet cutting, electrical discharge machining, and plasma cutting, are typically used for 2D machining
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Isolated or non-isolated mandibular fractures located between the mental foramina (interforaminal fractures).
Exclusion criteria
* Patients with relevant systemic diseases that affect bone healing. * Comminuted fractures in which it is difficult to fix.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tensile Strength | After fabrication of the plates (baseline biomechanical assessment) | Tensile strength will be measured using a universal testing machine (Instron) to evaluate the resistance of each plate to tensile forces according to standardized biomechanical testing protocols. Unit of Measure: Newton (N) Measurement Tool: Instron Universal Testing Machine. |
| Shear Strength | Immediately after fixation (within 24 hours) | Shear strength will be tested using the Instron universal testing machine to determine the resistance of the plate to shear loading. Time Frame: After fabrication of the plates (baseline biomechanical assessment) Unit of Measure: Newton (N) Measurement Tool: Instron Universal Testing Machine. |
| Outcome Measure | Immediately after fixation (within 24 hours) | Title: Overall Mechanical Stability Description: Overall biomechanical stability will be evaluated based on combined tensile, shear results. Time Frame: Within 24 hours after surgical fixation Unit of Measure: Stability index (unitless) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mouth Opening Measurement | 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery | Maximum inter-incisal distance will be measured using a digital caliper to assess functional recovery and detect any restrictions. Unit of Measure: Millimeters (mm) Measurement Tool: Digital caliper |
| Postoperative Infection Assessment | 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery | Infection will be evaluated using the CDC Surgical Site Infection (SSI) criteria, including redness, swelling, warmth, purulent discharge, fever \>38°C, and localized tenderness at the surgical site.Unit of Measure: Presence or absence (Yes/No) Measurement Tool: CDC SSI Diagnostic Criteria (clinical assessment) |
| Wound Healing Score | 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery | Wound healing will be assessed using the Landry, Turnbull, and Howley Wound Healing Index, which evaluates tissue color, bleeding on palpation, granulation tissue, and overall appearance. Unit of Measure: Score (0-5 scale) Measurement Tool: Landry, Turnbull & Howley Index (clinical scale) |
| Postoperative Edema Measurement | 1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery | Edema will be measured using standardized linear facial measurements (tragus-pogonion and gonion-pogonion distances) to quantify postoperative swelling. Unit of Measure: Millimeters (mm) Measurement Tool: Facial linear measurement with ruler/caliper. |
Countries
Egypt
Outcome results
None listed