Additive Versus Subtractive Manufacturing Techniques of Custom-Made Plates for the Fixation of Interforaminal Mandibular Fractures:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Tensile Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated or non-isolated mandibular fractures located between the mental foramina (interforaminal fractures).
排除标准
- •Patients with relevant systemic diseases that affect bone healing.
- •Comminuted fractures in which it is difficult to fix.
研究组 & 干预措施
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
干预措施: additive plating group (Device)
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
干预措施: subtractive plating group (Device)
结局指标
主要结局
Tensile Strength
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
FARIS INAD S ALANAZI
Principal Investigator, Master's Student, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University
Tanta University