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Evaluation of the efficacy and safety of early surgery and conservative treatment of infraorbital nerve compression injury in patients with Zingg A zygomatic maxillary fracture: a randomized, parallel controlled, open trial

Evaluation of the efficacy and safety of early surgery and conservative treatment of infraorbital nerve compression injury in patients with Zingg A zygomatic maxillary fracture: a randomized, parallel controlled, open trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036833
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Zingg A zygomatic maxillary fracture

Interventions

Experimental group:Decompression of infraorbital nerve combined with oral administration of neurotrophic drugs
Control group:Oral administration of neurotrophic drugs

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Maxillofacial CT confirms unilateral zygomatic maxillary fracture of patients with fracture line crossing infraorbital foramen and compression of infraorbital nerve; 2) Maxillofacial CT shows no obvious displacement of zygomatic-maxillary complex and the fracture is in accordance with Zingg A zygomatic maxillary fracture; 3) The main clinical manifestation of patients is infraorbital nerve dysfunction, with no obvious facial deformity, restriction of mouth opening or diplopia; 4) The time after injury is between 7 days and 30 days, and no obvious recovery of numbness could be observed during this period.

Exclusion criteria

Exclusion criteria: 1) Patients with brain injuries; 2) Patients with fractures of other craniofacial bones; 3) Patients with facial deformity, restriction of mouth opening or diplopia; 4) Patients who have history of craniofacial injuries or received craniofacial surgeries before; 5) Patients with severe hypertension, diabetes, heart disease or other diseases which fall in contraindications to surgery; 6) Patients who have history of drug allergy; 7) Patients who show recovery of numbness during waiting for treatment; 8) Patients with history of numbness of infraorbital area before.

Design outcomes

Primary

MeasureTime frame
Asymmetry index;Asymmetry index;

Secondary

MeasureTime frame
Recovery time of the sensory function of infraorbital nerve;Hospitalization costs;

Countries

China

Contacts

Public ContactJiewen Dai

Shanghai Ninth People's Hospital, Shanghai Jiaotong University, School of Medicine

daijiewen@163.com+86 15216713868

Outcome results

None listed

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