Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures

NCT07263633 | Completed

• 1 other identifier: TANTAOMSF-IFMF-149
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Mandibular Fracture

Keywords

Additive; Subtractive; Custom-Made Plates; Interforaminal; Mandibular; Fractures

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (4)

• 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

Study Arms (2)

additive plating group

EXPERIMENTAL

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

Device: additive plating group

subtractive plating group

ACTIVE COMPARATOR

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

Device: subtractive plating group

Interventions

subtractive plating group DEVICE

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

subtractive plating group

additive plating group DEVICE

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

additive plating group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Isolated or non-isolated mandibular fractures located between the mental foramina (interforaminal fractures).

You may not qualify if:

• Patients with relevant systemic diseases that affect bone healing.
• Comminuted fractures in which it is difficult to fix.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• FARIS I ALANAZI

  Faculty of Dentistry, Tanta University

  PRINCIPAL INVESTIGATOR

• Rafic R Bedir

  Faculty of Dentistry, Tanta University

  PRINCIPAL INVESTIGATOR

• Ahmed G Abushahba

  Faculty of Dentistry, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master's Student, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 4, 2025
• Study Start: December 28, 2024
• Primary Completion: July 30, 2025
• Study Completion: October 29, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)