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Background <p>Among facial skeletal injuries, mandibular fractures are highly prevalent, second after nasal bone fractures. Consequently, a lot of research has focused on treatment modalities for these fractures, to ensure faster healing &amp; rigid fixation. One of these modalities is the application of the Sagittal Split plate at the mandibular angle. The objective of this study is to compare the clinical and radiographic outcomes of the use of a novel Sagittal Split Osteotomy Plate (SSOP) design versus conventional two-miniplate fixation in the treatment of mandibular angle fractures, and to assess the biomechanical stability of the new design.</p> Materials and methods <p>In this pilot randomized controlled trial, 16 patients with mandibular angle fractures were randomly assigned (1:1 allocation ratio) using computer-generated block randomization into two groups. Group A (8) patients were treated using the new plate modified from Sagittal Split plate, and Group B (8) patients were treated using two conventional miniplates. Mechanical test bench was performed to measure plate strength &amp; mechanical stability of the new plate design. Clinical evaluations were performed at 24&#xa0;h, one, four, six and twelve weeks postoperative to assess operating time, pain, occlusion, wound healing &amp; interincisal mouth opening. In addition, radiographic assessments were conducted immediately postoperatively and at three months to evaluate the mean bone density at the fracture site.</p> Result <p>The study group showed reduced operating time. No statistically significant differences between the groups regarding occlusion, wound healing, postoperative pain and interincisal mouth opening. A statistically significant difference was observed regarding mean bone density of the study group after 3 months. The mean displacement of the mechanical test was 1.46&#xa0;mm under 60&#xa0;N of the new plate.</p> Conclusion <p>Within the limitations of this pilot study, the novel SSOP demonstrated reduced operative time and comparable short-term clinical outcomes to conventional double-miniplate fixation. Radiographically, higher bone density was observed at three months, and the prototype demonstrated acceptable baseline biomechanical outcomes during pre-clinical testing. While the SSOP represents a potential fixation alternative, larger longitudinal studies remain necessary to evaluate long-term clinical outcomes and to directly compare this prototype biomechanically against other established plates used for mandibular angle fractures.</p> Trial registration <p>This clinical trial was prospectively submitted for registration to ClinicalTrials.gov prior to the enrollment of the first participant (identifier NCT07103590; official public posting August 5, 2025).</p>

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A novel plate design versus two conventional miniplates for treatment of mandibular angle fractures (a pilot randomized controlled clinical trial)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月9日

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  • Peter N. El-Masry,
  • Nevein S. Mohamed,
  • Mohamed E. Saber

摘要

Background

Among facial skeletal injuries, mandibular fractures are highly prevalent, second after nasal bone fractures. Consequently, a lot of research has focused on treatment modalities for these fractures, to ensure faster healing & rigid fixation. One of these modalities is the application of the Sagittal Split plate at the mandibular angle. The objective of this study is to compare the clinical and radiographic outcomes of the use of a novel Sagittal Split Osteotomy Plate (SSOP) design versus conventional two-miniplate fixation in the treatment of mandibular angle fractures, and to assess the biomechanical stability of the new design.

Materials and methods

In this pilot randomized controlled trial, 16 patients with mandibular angle fractures were randomly assigned (1:1 allocation ratio) using computer-generated block randomization into two groups. Group A (8) patients were treated using the new plate modified from Sagittal Split plate, and Group B (8) patients were treated using two conventional miniplates. Mechanical test bench was performed to measure plate strength & mechanical stability of the new plate design. Clinical evaluations were performed at 24 h, one, four, six and twelve weeks postoperative to assess operating time, pain, occlusion, wound healing & interincisal mouth opening. In addition, radiographic assessments were conducted immediately postoperatively and at three months to evaluate the mean bone density at the fracture site.

Result

The study group showed reduced operating time. No statistically significant differences between the groups regarding occlusion, wound healing, postoperative pain and interincisal mouth opening. A statistically significant difference was observed regarding mean bone density of the study group after 3 months. The mean displacement of the mechanical test was 1.46 mm under 60 N of the new plate.

Conclusion

Within the limitations of this pilot study, the novel SSOP demonstrated reduced operative time and comparable short-term clinical outcomes to conventional double-miniplate fixation. Radiographically, higher bone density was observed at three months, and the prototype demonstrated acceptable baseline biomechanical outcomes during pre-clinical testing. While the SSOP represents a potential fixation alternative, larger longitudinal studies remain necessary to evaluate long-term clinical outcomes and to directly compare this prototype biomechanically against other established plates used for mandibular angle fractures.

Trial registration

This clinical trial was prospectively submitted for registration to ClinicalTrials.gov prior to the enrollment of the first participant (identifier NCT07103590; official public posting August 5, 2025).