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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100144
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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.
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Betriebszeit
Zeitfenster: der Tag der Operation
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der Tag der Operation
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Accuracy
Zeitfenster: before and 7 days after the surgery
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before and 7 days after the surgery
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026（085）
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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