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Research and application for rapid external fixation of mandibular fractures

Small-sample clinical trial study on the application of rapid external fixation for early fixation of the mandible

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111368
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-11-18
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular fracture, infection, tumor

Interventions

Small-sample clinical trials:Application for rapid external fixation of mandibular fractures

Sponsors

Department of oral and maxillofacial surgery,Stomatological hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Comminuted fractures. Severe open or infected fractures of the mandible caused by traffic accidents or other reasons; patients with mandibular fractures who also have concomitant craniocerebral injury, pneumothorax, or abdominal organ injury that make specialized treatment impossible; or patients whose specialized condition is acceptable but cannot undergo immediate open reduction and internal fixation of the mandible due to reasons such as severe hypertension, acute cerebral infarction, or unstable control of hyperthyroidism; 2.Related diseases such as osteomyelitis. Patients requiring temporary intraoperative fixation during mandibular reconstruction and repair surgery; or patients with severe infection leading to pathological fractures, such as those with destruction of the mandible accompanied by severe infection caused by mandible osteomyelitis, medication-induced osteonecrosis, or radiation-induced osteonecrosis and other inflammatory diseases, who are not suitable for immediate partial mandibulectomy with simultaneous bone grafting or prosthetic repair for mandibular reconstruction, or who require temporary fixation with a reconstruction plate; 3.Mandibular defects caused by tumors or other reasons. Patients requiring temporary intraoperative fixation during mandibular reconstruction and repair surgery due to tumors or other causes; or patients requiring segmental mandibulectomy who are unable to undergo autologous bone grafts such as fibula or iliac bone transplantation, or alternative prosthetic repair at this stage, or patients with existing implants experiencing infection or other issues; 4.Patients who are fully informed of the content, benefits, and possible risks of this research project, and agree to participate in this study; 5.Patients who can communicate and interact normally, and are able to cooperate actively.

Exclusion criteria

Exclusion criteria: 1.Patients who meet the conditions for surgical open reduction and rigid internal fixation treatment; 2.Patients whose mandibular defect range involves both ascending rami, making it impossible to fix with a unilateral external fixation device; 3.Patients with epilepsy or mental disorders who are unable to cooperate with postoperative management; 4.Patients who are unwilling to bear the potential risks of this project, and thus cannot meet the follow-up requirements; 5.Patients without complete and authentic clinical data.

Design outcomes

Primary

MeasureTime frame
The condition of stent loosening;

Secondary

MeasureTime frame
Surgery time;Status of surgical site infection; Hematology test;

Countries

China

Contacts

Public ContactTian Lei

Department of oral and maxillofacial surgery,Stomatological hospital, Air Force Medical University

yanxin9701@163.com+86 29 8477 6557

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026