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Tooth and Bone-borne Cutting/Repositioning Guide and Patient-specific Implant(PSI) (PSI)

2026年8月30日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Xiaoshuang Guo, M.D.
  • 电话号码：+86 13121234163
  • 邮箱：gxsinjnu@126.com

研究联系人备份

学习地点

  • 中国
      • Beijing、中国、100144
        • 招聘中
        • Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Age ranged from 18 to 40 years old.
  2. 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.
  3. Patients were scheduled for bimaxillary orthognathic surgery, with optional adjunctive procedures including maxillary and mandibular subapical osteotomy and genioplasty.
  4. 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.
  5. Patients agreed to complete follow-up examinations and provided signed informed consent.

Exclusion Criteria:

  1. Patients who refused to participate in the present study.
  2. 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.
  3. Presence of body dysmorphic disorder, a history of psychiatric disorders, or excessively demanding patients with unrealistic treatment expectations.
  4. Presence of facial skeletal tumors.
  5. Patients who required revision surgery after previous orthognathic procedures.
  6. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
程序：bimaxillary surgery(Lefort I and SSRO)
All patients underwent surgery-first bimaxillary orthognathic surgery, with concomitant optional procedures including maxillary and mandibular subapical osteotomy and genioplasty.
有源比较器：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.
程序：bimaxillary surgery(Lefort I and SSRO)
All patients underwent surgery-first bimaxillary orthognathic surgery, with concomitant optional procedures including maxillary and mandibular subapical osteotomy and genioplasty.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Linear deviation
大体时间：7 days and 1 year
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.
7 days and 1 year

次要结果测量

结果测量
措施说明
大体时间
Angular deviation
大体时间：7 days and 1 year
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.
7 days and 1 year
Soft tissue change
大体时间：1 year
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.
1 year
satisfatory questionnaire
大体时间：1 year
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking Union Medical College

合作者

Beijing Municipal Health Commission

调查人员

  • 研究主任：Guodong Song、Chinese Academy of Medical Sciences, Peking Union Medical College, Plastic Surgery Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月3日

初级完成 (估计的)

2028年6月8日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月30日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026-4-4043

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Raw data of linear/angular deviation, soft tissue change, and questionnaire

IPD 共享时间框架

Date of public release: The day of online publication of the article (expected December 2029)

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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