Oral disease
Conditions
Interventions
Experimental group:3D-printed customize-made titanium osteotomy and osteosynthesis plate
Control group:The traditional occlusal splint
Sponsors
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-35 years male or female; 2. Diagnosis with skeletal class II malocclusion; 3. Patients with TMJ instability, including: (1) The condyle is not in the centric relation during the preoperative CT scan; (2) Double or multiple occlusion relationship are found in clinical examination; (3) CT and MRI show that the condyle has different degrees of absorption. 4. Orthognathic surgical plan is non-segmental bimaxillary osteotomies; 5. No reject reaction to the titanium plate, titanium nails, and other implants; 6. The patient has not participated in other clinical trials within 3 months before the beginning of the current trial; 7. The patient was healthy, with no chronic, systemic disease or, mental illness; 8. Patients informed consent and signed the consent form.
Exclusion criteria
Exclusion criteria: 1. With a history of surgery to the maxilla and mandible; 2. Previous or current with jaw trauma, tumor, or soft tissue defect; 3. Orthognathic surgical plan is single-jaw surgery or includes segmental osteotomy; 4. Diagnosis with craniofacial anomaly syndrome; 5. With reject reaction to the titanium plate, titanium nails, and other implants; 6. With acute severe infection or chronic infection in the acute stage; 7. With radiation-induced osteomyelitis, acute and chronic osteomyelitis, and osteoporosis; 8. Pregnant or lactating females; 9. Patients were complicated with uncontrolled substantial diseases of important organs such as the heart and kidney; 10. With mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The centroid position of the maxilla; | — |
Secondary
| Measure | Time frame |
|---|---|
| The centroid position of the mandible;The linear difference of maxilla;The angular difference of maxilla;The linear difference of mandible;The angular difference of mandible; | — |
Countries
China
Contacts
Public ContactLei Zhang
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed