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Comparative evaluation of clinical efficacy of 3D printed titanium guide plate and individual retainer plate and navigation assisted reconstructive surgery in patients with mid-facial trauma

Comparative evaluation of clinical efficacy of 3D printed titanium guide plate and individual retainer plate and navigation assisted reconstructive surgery in patients with mid-facial trauma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058957
Enrollment
Unknown
Registered
2022-04-20
Start date
2021-09-15
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Midfacial trauma

Interventions

Experimental group:3D printing of titanium metal guide plate with individual fixation plate
Control group:Navigation-assisted operation

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-74 years; 2. Currently, there is no contraindication of craniomaxillofacial surgery; 3. 1 week to 3 months after trauma; 4. Maxillofacial CT was taken to confirm the presence of midfacial fracture, obvious appearance deformity or dysfunction and the need for surgical rectification; 5. Single-discipline or multidisciplinary therapy is required.

Exclusion criteria

Exclusion criteria: 1. Patients with poor general condition who cannot tolerate long-term maxillofacial fracture operation; 2. Patients with craniocerebral trauma with poor prognosis, such as brain stem injury, and high probability of plant survival after surgery; 3. Patients with serious systemic diseases, including acute infections, mental illness and a wide range of serious systemic diseases, such as hypertension, heart disease and diabetes; 4. Patients with osteoporosis, osteomyelitis and other systemic or local diseases that affect the prognosis; 5. Pregnant and lactating patients; 6. Patients who are unable to respond to treatment.

Design outcomes

Primary

MeasureTime frame
Accuracy of skeletal reduction;

Secondary

MeasureTime frame
Occlusion;Diplopia;Nasal ventilation function;Operating time;Amount of bleeding;Hospitalization days;

Countries

China

Contacts

Public ContactZhang Shilei

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research C

leinnymd@hotmail.com+86 13701689301

Outcome results

None listed

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