NCT07263633|Completed
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Sponsor study identifier
interventional
16
1 country
1
Study Start
December 28, 2024
Actual (reported)Primary Completion
July 30, 2025
Actual (reported)Study Completion
October 29, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 29, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 28, 2024
Actual (reported)July 30, 2025
Actual (reported)October 29, 2025
Actual (reported)November 16, 2025
Actual (reported)December 4, 2025
Actual (reported)Tensile Strength
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.
After fabrication of the plates (baseline biomechanical assessment)
Shear Strength
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.
Immediately after fixation (within 24 hours)
Outcome Measure
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)
Immediately after fixation (within 24 hours)
Mouth Opening Measurement
1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Wound Healing Score
1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Postoperative Edema Measurement
1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Postoperative Infection Assessment
1 week, 2 weeks, 1 month, 3 months, and 6 months after surgery
Additive manufacturing typically describes any process where material is gradually added, layer by layer, to form a final product. The term is often used interchangeably with 3D printing and rapid prototyping, although rapid prototyping can also involve other techniques beyond additive methods
In subtractive manufacturing, objects are created by progressively removing material from a solid block or sheet through processes such as cutting, drilling, boring, or grinding. While these processes can be performed manually, they are more commonly executed using computer numeric control (CNC). CNC machining is the most widely used subtractive manufacturing process today
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
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
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527, Egypt
FARIS I ALANAZI
Faculty of Dentistry, Tanta University
Rafic R Bedir
Faculty of Dentistry, Tanta University
Ahmed G Abushahba
Faculty of Dentistry, Tanta University
16 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2025
First Posted
December 4, 2025
Study Start
December 28, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 30, 2025
Actual (reported)Study Completion
October 29, 2025
Actual (reported)Last Updated
December 4, 2025
Record last verified: 2025-11
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