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A clinical trial to study the effects of two point fixation through intraoral and extraoral approach in patients with zygomatic maxillary complex fractures

Comparison of intraoral versus extraoral approach in two point fixation of zygomatic complex fractures- a randomised control trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042745
Enrollment
30
Registered
2022-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: Y00- Assault by blunt object Health Condition 2: Y29- Contact with blunt object, undetermined intent Health Condition 3: V224- Motorcycle driver injured in collision with two- or three-wheeled motor vehicle in traffic accident Health Condition 4: V124- Pedal cycle driver injured in collision with two- or three-wheeled motor vehicle in traffic accident

Interventions

Intervention1: Two point fixation at zygomatic maxillary complex fractures: Two point fixation involves 1.Zygomatic maxillary buttress and infraorbital rim 2.Frontozygomatic suture and infraorbital ri

Sponsors

SAKTHISRI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Unilaterally displaced Zygomatic complex fractures diagnosed with preoperative clinical and radiological evaluation including 3DCT 2.Patients above 18 years of age 3.Patients with preoperative infraorbital nerve paraesthesia also included 4.Patient who gave consent to participate

Exclusion criteria

Exclusion criteria: 1.Patients with systemic complications who are not fit to undergo surgical intervention under General Anaesthesia 2.Isolated Zygomatic arch fractures 3.Patient with panfacial fractures 4.Patient with comminuted zygomatic fractures 5.Preoperative ophthalmologic evaluation suggested intervention

Design outcomes

Primary

MeasureTime frame
Restoration of anatomic form AestheticsTimepoint: 3 months

Secondary

MeasureTime frame
Function 1. Neurosensory assessment 2. Electromyographic assessmentTimepoint: 3 months

Countries

India

Contacts

Public ContactSakthisri Vivekanandan

Karpaga Vinayaga Institute of Dental Sciences

dr.guhan@gmail.com9841263109

Outcome results

None listed

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