Retrospective Study on the Application of Tooth-bone Dual-support Osteotomy/Location Plate in "Surgery-first" Orthognathic Treatment
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100144
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- Age: 18 to 40 years old.
- Diagnosis: Patients treated at Plastic Surgery Hospital, Chinese Academy of Medical Sciences. Diagnosed with dentofacial deformity upon comprehensive evaluation by two senior attending plastic surgeons.
- Surgical plan: Scheduled for bimaxillary orthognathic surgery, which may be combined with subapical osteotomy of the maxilla and mandible or genioplasty.
- Treatment protocol: 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.
- Agreement to follow-up and signed informed consent form.
Exclusion Criteria:
- Presence of comorbid diseases or symptoms that may increase surgical risks or compromise surgical outcomes, as determined by two senior plastic surgeons, including but not limited to hypertension, diabetes, immune thrombocytopenic purpura, and hemoglobin (Hb) ≤ 100 g/L.
- Body dysmorphic disorder, history of psychiatric disorders, or excessively demanding patients with unrealistic expectations.
- Facial skeletal tumors.
- Revision surgery after prior orthognathic procedures.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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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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. |
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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.
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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driftstid
Tidsramme: operationsdagen
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operationsdagen
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Accuracy
Tidsramme: before and 7 days after the surgery
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before and 7 days after the surgery
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026（085）
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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