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A multicenter randomized clinical study of using a three-dimensional printed patient personalized titanium plate in jaw surgery

A prospective, multicenter, randomized, clinical controlled trial of using a three-dimensional printed patient personalized titanium plate in orthognathic surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11838566
Enrollment
100
Registered
2022-06-06
Start date
2022-07-20
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Management of dentofacial deformities through an orthognathic surgical intervention Surgery

Interventions

A prospective, randomized multi-center clinical trial study planned to compare the accuracy of bone positioning following orthognathic surgery between 3D printed personalized titanium plates patient g

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with dentofacial malformations requiring orthognathic surgery 2. Aged 18-45 years 3. Willing to participate in the clinical study and sign informed consent of meeting the above-mentioned criteria

Exclusion criteria

Exclusion criteria: 1. Patient with maxillofacial deformities secondary to cleft lip and palate, tumor, trauma and other congenital factors 2. Patients with syndromes such as hemifacial microsomia, first and second arch syndrome, etc 3. Patients who had undergone previous jaw surgery

Design outcomes

Primary

MeasureTime frame
The accuracy of using 3D printed titanium plates through evaluation of the post-operative CT scan with the pre-operative 3D planning using a 3D Slicer software program

Secondary

MeasureTime frame
Current secondary outcome measures as of 05/06/2024: Long-term stability of the 3d printed personalized plates used in orthognathic surgery Any abnormalities related to the use of 3D plating were assessed using a blood sample before and after the surgery _____ Previous secondary outcome measures: Any abnormalities related to the use of 3D plating assessed using a blood sample before and after the surgery

Countries

China

Outcome results

None listed

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