Used for the fixation, reconstruction and repair of maxillofacial fractures and defects.
Conditions
Interventions
experimental group:3D printing of maxillofacial bone defect repair
control group:Titanium plate for internal fixation
Sponsors
West China Stomatological Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in the study and sign the informed consent; 2. Age 18~80, gender unlimited; 3. According to the three-dimensional reconstruction model of maxillofacial bone, the length of the defect after osteotomy was preliminarily determined, and indications for maxillofacial bone defect repair were needed, including (one of the following options): (1) maxillofacial defect; (2) mandible defect; (3) orbital floor defect; (4) zygomatic defect; (5) forehead defect; (6) The researchers consider that other indications are suitable for the use of prostheses to repair maxillofacial bone defects. 4. Those who can communicate well with the investigator and follow the requirements of the experiment.
Exclusion criteria
Exclusion criteria: 1. People with a history of metal allergy; 2. Surgical site infection or acute systemic infection; 3. Patients who cannot tolerate surgery for other systemic diseases, 4. Life expectancy of less than one year; 5. Advanced oral and maxillofacial malignant tumors that are not effectively controlled; 6. No surgical history within three months at the site to be implanted; 7. Pregnant or lactating women, or women who plan to become pregnant within the next six months; 8. Suffering from severe epilepsy or mental illness; 9. People with alcohol dependence or drug addiction; 10. Subjects who have had radiation therapy or have planned subsequent radiation therapy; 11. Other organologic or functional diseases associated with the subject may limit their participation in the study, prevent them from complying with the follow-up or affect the scientific integrity of the study; 12. Subjects with severe osteoporosis who had taken bisphosphonates within 6 months; 13. Participated in other clinical trials within three months upon enrollment; 14. Those who are considered by the investigator to be unsuitable to participate in the clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The product was effective 180 days ±15 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of restoration effect;UW-QOL;Operational satisfaction;Self-evaluation of facial appearance satisfaction;Evaluation of mouth opening degree;time of operation;Surgical blood loss; | — |
Countries
China
Contacts
Public ContactLei Liu
Outcome results
None listed