Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI) (PSI)
30 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
50
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Xiaoshuang Guo, M.D.
- Número de telefone: +86 13121234163
- E-mail: gxsinjnu@126.com
Estude backup de contato
- Nome: Xiaolei Jin, M.D.
- E-mail: zxyy16jxl@163.com
Locais de estudo
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Beijing, China, 100144
- Recrutamento
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Contato:
- Xiaoshuang Guo, M.D.
- Número de telefone: +86 13121234163
- E-mail: gxsinjnu@126.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Linear deviation
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Angular deviation
Prazo: 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
Prazo: 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
Prazo: 1 year
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1 year
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Guodong Song, Chinese Academy of Medical Sciences, Peking Union Medical College, Plastic Surgery Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de junho de 2026
Conclusão Primária (Estimado)
8 de junho de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
28 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2026-4-4043
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Raw data of linear/angular deviation, soft tissue change, and questionnaire
Prazo de Compartilhamento de IPD
Date of public release: The day of online publication of the article (expected December 2029)
Critérios de acesso de compartilhamento 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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .