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A prospective, multicenter, randomized, controlled clinical trial of using three-dimensional printed patient personalized titanium plate in Orthognathic Surgery

A prospective, multicenter, randomized, controlled clinical trial of using three-dimensional printed patient personalized titanium plate in Orthognathic Surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060289
Enrollment
Unknown
Registered
2022-05-26
Start date
2021-01-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Maxillofacial Deformities

Interventions

Titanium plates:Use of commercially available titanium plates in orthognathic surgery
3D printed personalized titanium plates:Use of 3-Dimensional printed personalized titanium plates in orthognathic surgery

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Patients with dental and maxillofacial deformities requiring orthognathic surgery; 3. Willing to participate in this clinical study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Tooth and maxillofacial deformities secondary to cleft lip and palate, tumor, trauma, or iatrogenic factors; 2. Patients with syndrome such as hemifacial atrophy, first and second parotid arch syndrome, etc; 3. Those who have undergone jaw surgery.

Design outcomes

Primary

MeasureTime frame
Post-operative accuracy of bone positioning between pre-operative digital planning following and post-operative outcome;

Secondary

MeasureTime frame
Decrease in the opreation timing;

Countries

China

Contacts

Public ContactSongsong Zhu

West China Hospital of Stomatology, Sichuan University

zss_1977@163.com+86 13882232020

Outcome results

None listed

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