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

NCT ID: NCT07263633

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-10-29

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.

Conditions

Anterior Mandibular Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

additive plating group

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

Group Type: EXPERIMENTAL

additive plating group

Intervention Type: 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

subtractive plating group

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

Group Type: ACTIVE_COMPARATOR

subtractive plating group

Intervention Type: 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

Interventions

subtractive 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

Intervention Type: DEVICE

additive 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

FARIS INAD S ALANAZI

Principal Investigator, Master's Student, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FARIS I ALANAZI

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University

Rafic R Bedir

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University

Ahmed G Abushahba

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University

Locations

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

TANTAOMSF-IFMF-149

Identifier Type: -

Identifier Source: org_study_id