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| Name | Class |
|---|---|
| Southern Medical University, China | OTHER |
| Meizhou People's Hospital | OTHER |
| Shenzhen Stomatology Hospital | UNKNOWN |
| Guangzhou Medical University |
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This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. The study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. Participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Titanium Mesh | Experimental | Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration. |
|
| Prefabricated Titanium Mesh | Active Comparator | Use prefabricated titanium mesh for guided bone regeneration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh | Procedure | Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration.In the bone grafting surgery, the additive-manufactured personalized titanium mesh is used to secure the bone substitutes, with fixation screws used to secure the titanium mesh. |
| Measure | Description | Time Frame |
|---|---|---|
| Osteogenesis efficiency | Based on the oral CBCT imaging data, bone volume is reconstructed for preoperative, the day of surgery, and six months after surgery. Bone volume changes are assessed by using mimics as the bone resorption rate. The bone formation effectiveness is evaluated based on the bone resorption rate. | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of titanium mesh exposure | Record and observe the exposure of the titanium mesh during the healing process. | 14 days, 1 month, 6 months, 1 year, and 2 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayun Xu | Contact | +86 135 3354 6195 | hsujiayun@outlook.com | |
| Jinming Wang | Contact | +86 135 3545 8675 | wjinm@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jinming Wang | Hospital of Stomatology, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Stomatology, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510030 | China |
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| OTHER |
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| Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh | Procedure | In bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh. |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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