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The goal of this observational study is to learn the accuracy of tooth-bone dual-support osteotomy/location guide plate compared with conventional CAD/CAM interocclusal splints in "surgery-first" orthognathic surgeries.
The main question it aims to answer is:
Does the tooth-bone dual-support osteotomy/location guide plate performed better in accuracy? Does the tooth-bone dual-support osteotomy/location guide plate saved operation time? Participants already underwent orthognathic surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tooth-bone dual support cutting/repositioning guide | This tooth-bone dual support cutting/repositioning guide is a custom surgical template used in orthognathic surgery. It integrates both tooth-borne and bone-borne fixation for high stability. It accurately defines osteotomy lines and repositioning paths, improves surgical precision, reduces intraoperative error, and enhances postoperative occlusion and facial symmetry. |
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| interocclusal splint | An interocclusal splint is a custom-made acrylic appliance widely used in orthognathic surgery. It establishes stable, reproducible maxillomandibular relationship, guides precise repositioning of jaws, maintains planned occlusion intraoperatively, and improves surgical accuracy and postoperative stability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orthognathic surgery | Procedure | Orthognathic surgery corrects congenital and acquired dentofacial deformities by surgically repositioning the maxilla, mandible, or chin. It treats severe malocclusion, facial asymmetry, retrognathia, prognathism, and functional issues such as breathing, chewing, and speech difficulties. Performed in conjunction with orthodontic treatment, the surgery uses pre-surgical planning, interocclusal splints, and cutting guides to achieve accurate bony repositioning and stable internal fixation. It improves both facial aesthetics and stomatognathic function, greatly enhancing patients' quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | before and 7 days after the surgery | |
| operation time | the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients primarily diagnosed as "dentofacial deformities" who are scheduled for "surgery-first" bimaxillary orthognathic surgery.
They are cases eligible for the surgery-first approach after joint assessment by craniomaxillofacial surgeons and orthodontists. Orthodontists confirm that satisfactory occlusal relationships can be achieved via postoperative orthodontic treatment. Preoperative requirements are as follows: no or mild anterior crowding, flat or shallow Spee's curve, slight incisor inclination, harmonious maxillary and mandibular dental arches, and at least three stable occlusal contacts in the transitional occlusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100144 | China |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
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