Using 3D-printed surgical plates for jaw reconstruction
Computer-Assisted Jaw Reconstruction Using 3D-Printed Patient-Specific Surgical Plates Versus Conventional Surgical Plates: A Randomised Controlled Clinical Trial
This study is testing if 3D-printed titanium plates for jaw surgery can provide better accuracy and results compared to traditional surgical plates for patients needing jaw reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04635865 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the surgical accuracy and efficiency of 3D-printed patient-specific titanium surgical plates against conventional surgical plates in jaw reconstruction. It is a randomized controlled trial involving patients with maxillary or mandibular neoplasms, inflammatory conditions, or congenital diseases requiring reconstructive surgery. The study will evaluate the primary endpoint of reconstruction accuracy and secondary endpoints related to surgical outcomes. Participants will undergo computer-assisted surgery with either type of plate to determine which method yields better results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with maxillofacial benign or malignant tumors or other conditions requiring jaw reconstruction.
Not a fit: Patients who are pregnant or have systemic conditions that impair bone healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise and efficient jaw reconstructions, improving patient outcomes.
How similar studies have performed: Previous studies on 3D printing in surgical applications have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than 18 years, of both gender; * Provision of signed and dated informed consent form; * Diagnosed with maxillofacial benign or malignant tumours or inflammatory or congenital diseases and indicated for computer-assisted jaw surgery; * Primary or secondary reconstruction with autogenous bony free flaps or graft will be needed; * Titanium plates will be used for internal fixation for the reconstruction surgery; * Agree to comply with follow-up procedures. Exclusion Criteria: * Patients who are pregnant; * Patients who have medically compromised conditions and cannot tolerate the surgery; * Systemic conditions or diseases that violate the normal bone healing; * Patients who are unable to take the preoperative and postoperative CT/CBCT scans; * Patients who are unable to have a two-week period prior to surgery, for virtual surgery simulation, 3D patient-specific surgical plate design and fabrication.
Where this trial is running
Hong Kong
- The Prince Philip Dental Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Yuxiong Su, Dr. — The University of Hong Kong
- Study coordinator: Yuxiong Su, Dr.
- Email: richsu@hku.hk
- Phone: 852 2859 0267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.