Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI) (PSI)
3. června 2026 aktualizováno: Xiaolei Jin, Peking Union Medical College
A Prospective, Randomized, Controlled, Single-blind Study on the Hybrid Tooth and Bone-supported Cutting and Repositioning Guides Versus Computer-aided Design/Computer-aided Manufactured Splints in "Surgery-first" Orthognathic Surgery
Dentofacial deformity refers to a group of disorders characterized by malocclusion and facial asymmetry resulting from developmental abnormalities of the maxilla and mandible, which cause morphological and positional anomalies of the jaws. Compared with the traditional orthodontics-orthognathic surgery-orthodontics treatment protocol, the surgery-first approach has witnessed a continuous expansion of its clinical application scope. Nevertheless, academic controversies persist regarding its indication boundaries, postoperative jaw stability, and adaptive changes of the temporomandibular joint.
In orthognathic surgery, computer-aided design/computer-aided manufacturing (CAD/CAM) surgical guides indirectly determine the three-dimensional spatial positions of the maxilla and mandible through occlusal relationships. The tooth-bone dual-supported osteotomy and positioning guide combined with pre-bent patient-specific implants (PSIs) forms a novel surgical guide system that enables independent and direct positioning of the maxilla. Theoretically, this system can eliminate errors derived from mandibular positional instability and thereby improve surgical accuracy. However, comparative studies investigating the clinical application of these two types of guides in surgery-first orthognathic surgery are still lacking.
This prospective, randomized, controlled, single-blind clinical study aimed to explore the clinical value of PSIs and conventional CAD/CAM guides in surgery-first orthognathic surgery, with primary outcomes focusing on surgical accuracy, postoperative jaw stability, and temporomandibular joint alterations. The findings will provide evidence-based medical support for the expanded application of this novel technique in precision orthognathic surgery.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
50
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Xiaoshuang Guo, M.D.
- Telefonní číslo: +86 13121234163
- E-mail: gxsinjnu@126.com
Studijní záloha kontaktů
- Jméno: Xiaolei Jin, M.D.
- E-mail: zxyy16jxl@163.com
Studijní místa
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Beijing, Čína
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Kontakt:
- Xiaoshuang Guo, M.D.
- Telefonní číslo: +86 13121234163
- E-mail: gxsinjnu@126.com
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Age ranged from 18 to 40 years old.
- Patients were diagnosed with dentofacial deformity and received treatment at the Plastic Surgery Hospital, Chinese Academy of Medical Sciences. The diagnosis was confirmed via comprehensive evaluation by two senior attending plastic surgeons.
- Patients were scheduled for bimaxillary orthognathic surgery, with optional adjunctive procedures including maxillary and mandibular subapical osteotomy and genioplasty.
- Patients were indicated for the surgery-first approach based on joint assessment by craniomaxillofacial surgeons and orthodontists. Orthodontists confirmed that satisfactory occlusal relationships could be achieved through postoperative orthodontic treatment. Preoperative dental conditions met the following requirements: no or mild anterior dental crowding, flat or shallow Spee's curve, slight incisor inclination, harmonious maxillary and mandibular dental arches, and at least three stable occlusal contacts under transitional occlusion.
- Patients agreed to complete follow-up examinations and provided signed informed consent.
Exclusion Criteria:
- Patients who refused to participate in the present study.
- Presence of comorbidities that may increase surgical risks or impair surgical outcomes, as assessed by two senior plastic surgeons, including but not limited to hypertension, diabetes, immune thrombocytopenic purpura, and hemoglobin (Hb) level ≤ 100 g/L.
- Presence of body dysmorphic disorder, a history of psychiatric disorders, or excessively demanding patients with unrealistic treatment expectations.
- Presence of facial skeletal tumors.
- Patients who required revision surgery after previous orthognathic procedures.
- Cases judged unable to achieve stable occlusal relationships through postoperative orthodontic treatment following joint evaluation by craniomaxillofacial surgeons and orthodontists, including patients with severe dental crowding, maxillomandibular arch width discrepancy, temporomandibular joint disorders, or periodontal diseases.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: PSI group
Tooth-bone borne osteotomy and repositioning guides combined with patient-specific implants constitute the PSI group for short.
Preoperative craniomaxillofacial computed tomography (CT) data of patients were imported for three-dimensional reconstruction.
Surgical plans, including genioplasty procedures, were collaboratively formulated by surgeons and orthodontists with full consideration of patients' personal preferences.
Custom tooth-bone dual-supported osteotomy and positioning guides for both the maxilla and mandible were digitally designed and subsequently fabricated.
A partial skull model was printed preoperatively, on which custom titanium plates were pre-bent in advance in strict accordance with the established surgical protocol.
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All patients underwent surgery-first bimaxillary orthognathic surgery, with concomitant optional procedures including maxillary and mandibular subapical osteotomy and genioplasty.
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Aktivní komparátor: CAD/CAM group
Patients' preoperative craniomaxillofacial computed tomography (CT) data were imported for three-dimensional (3D) reconstruction.
Surgeons and orthodontists collaboratively formulated individualized surgical plans based on patients' preferences, including genioplasty procedures, followed by the design and fabrication of CAD/CAM intermediate and final surgical guides.
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All patients underwent surgery-first bimaxillary orthognathic surgery, with concomitant optional procedures including maxillary and mandibular subapical osteotomy and genioplasty.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Linear deviation
Časové okno: 7 days and 1 year
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Following the superimposition of preoperative virtual surgical planning models and postoperative actual craniomaxillofacial computed tomography (CT) datasets, manual registration was performed based on anatomical landmarks including the nasion, foramen magnum, infraorbital point, zygomatic bone, and zygomatic arch.
Linear deviations of the A-point, B-point, canine teeth, and first molars relative to the Frankfort horizontal plane, facial midsagittal plane, and coronal plane were measured and recorded.
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7 days and 1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Angular deviation
Časové okno: 7 days and 1 year
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Following the superimposition of preoperative virtual surgical planning models and postoperative actual craniomaxillofacial computed tomography (CT) datasets, manual registration was performed based on anatomical landmarks including the nasion, foramen magnum, infraorbital point, zygomatic bone, and zygomatic arch.
Angular deviations of the A-point, B-point, canine teeth, and first molars relative to the Frankfort horizontal plane, facial midsagittal plane, and coronal plane were measured and recorded.
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7 days and 1 year
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Soft tissue change
Časové okno: 1 year
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Soft tissue changes were evaluated based on three-dimensional facial scan data acquired using a 3dMD system.
Following the superimposition of preoperative virtual surgical planning models and postoperative actual facial scan datasets, changes in soft tissue landmarks were assessed, including the nasal base, lips, nose, etc.
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1 year
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satisfatory questionnaire
Časové okno: 1 year
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1 year
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Guodong Song, Chinese Academy of Medical Sciences, Peking Union Medical College, Plastic Surgery Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
8. června 2026
Primární dokončení (Odhadovaný)
8. června 2028
Dokončení studie (Odhadovaný)
31. prosince 2028
Termíny zápisu do studia
První předloženo
28. května 2026
První předloženo, které splnilo kritéria kontroly kvality
3. června 2026
První zveřejněno (Aktuální)
8. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2026-4-4043
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Raw data of linear/angular deviation, soft tissue change, and questionnaire
Časový rámec sdílení IPD
Date of public release: The day of online publication of the article (expected December 2029)
Kritéria přístupu pro sdílení IPD
The raw data will be published as supplementary materials alongside the full text on the official platform of the target journal, and available for free download and access by readers.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
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Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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