Comparison of Accuracy of Maxilla Between Virtual Surgical Planning and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Differences in the anteroposterior, mediolateral, and superoinferior changes of the maxillary landmarks were calculated to assess accuracy and validate the effectiveness of virtual surgical planning
研究概览
简要总结
Study Title Comparison of Maxillary Accuracy Between Virtual and Conventional Surgical Planning in Bimaxillary Orthognathic Surgery: A Randomized Controlled Trial Study Design
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Type: Prospective, single-center, randomized, blinded, case-controlled trial
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Location: National Hospital of Odonto-Stomatology, Ho Chi Minh City
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Period: August 2023 - February 2025
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Sample size: 20 patients
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Ethical approval: Granted by the University of Medicine and Pharmacy at HCMC (Approval No. 647/HĐĐĐ-ĐHYD) Inclusion Criteria
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Patients aged 18-30 years
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Diagnosed with malocclusion requiring bimaxillary orthognathic surgery
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Completed presurgical orthodontic treatment Exclusion Criteria
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Cleft lip/palate, craniofacial syndromes
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Deformities due to trauma, tumors, or iatrogenic causes
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TMJ disorders
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History of previous orthognathic surgery
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Planned multipiece Le Fort I osteotomy Randomization and Blinding
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All patients underwent both 2D and 3D surgical planning.
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Two splints (CSP and VSP) were fabricated for each patient.
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Intraoperative randomization was performed by an OR nurse.
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The surgical team and data analysts were blinded to group allocation.
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Groups were revealed only after data analysis. Groups
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Test group (VSP): 3D virtual planning, simulation, and 3D-printed splints
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Control group (CSP): 2D cephalometric planning, model surgery, conventional resin splints Surgical Procedure
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All patients underwent Le Fort I and BSSO
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Maxilla-first approach with fixation using 4 miniplates
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Mandibular repositioning using final splint and fixed with 2 miniplates per side
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All surgeries performed by a single experienced surgeon Data Collection & Measurements
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CT scans before and 2 weeks after surgery
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Superimposition using Invivo 7.0 software (voxel-based registration)
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Measured landmark changes (A point, ANS, U1, U3, U6) in X (medial-lateral), Y (anterior-posterior), and Z (vertical) directions
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Compared:
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2D plan (P2D) vs. 3D plan (P3D)
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P3D vs. actual postoperative result
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VSP vs. CSP accuracy Statistical Analysis
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ICC used to test measurement reliability (10 patients, remeasured after 2 weeks)
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Normality tested
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Paired t-test/Wilcoxon for planned vs. actual
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Independent t-test/Mann-Whitney for between-group comparisons
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Significance set at p < 0.05
详细描述
Materials and Methods Study Design This study was conducted as a prospective, single-center, randomized, and blinded case-controlled trial. The research protocol was reviewed and approved by the Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 647/HĐĐĐ-ĐHYD). All participants were fully informed of their treatment options and provided written informed consent prior to enrollment. The study adhered to ethical guidelines for clinical research, ensuring the protection of participants' rights, safety, and confidentiality.
Study Subjects The study was carried out at the National Hospital of Odonto-Stomatology in Ho Chi Minh City between August 2023 and February 2025. Eligible participants were aged 18 to 30 years and diagnosed with malocclusion requiring bimaxillary orthognathic surgery.
Exclusion criteria included:
- Cleft lip and/or palate or craniofacial syndromes
- Facial deformities resulting from trauma, tumors, or iatrogenic causes
- Temporomandibular joint disorders
- Previous history of orthognathic surgery
- Indication for multipiece Le Fort I osteotomy A total of 20 patients met the inclusion criteria and agreed to participate. All patients had completed presurgical orthodontic treatment prior to surgery.
Randomization and Blinding Each patient underwent both two-dimensional (2D) lateral cephalometric analysis and three-dimensional (3D) virtual surgical planning preoperatively. For each case, both a conventional surgical splint and a 3D-printed splint were fabricated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malocclusion requiring orthognathic surgery
排除标准
- •cleft lip and palate congenital abnormalities
- •the facial deformities were caused by trauma, tumor, or iatrogenic factors
- •temporomandibular joint disorders
- •history of previous orthognathic surgery
- •patients scheduled for multipiece Le Fort I osteotomy
研究组 & 干预措施
CSP Group (Conventional Resin Occlusal Splint)
Splints were manually fabricated based on 3D planning movement values
VSP Group
Digital surgical splints were generated using Dolphin software and a Form 3D printer
干预措施: VSP Group (Device)
结局指标
主要结局
Differences in the anteroposterior, mediolateral, and superoinferior changes of the maxillary landmarks were calculated to assess accuracy and validate the effectiveness of virtual surgical planning
时间窗: From August 2023 to February 2025
The accuracy of surgical outcomes was evaluated through: Positional Change of A Point, ANS, maxillary central incisors midpoint (U1), left maxillary central incisor (U1L), right maxillary central incisor (U1R), Maxillary Canines (U3L, U3R), Maxillary First Molars (U6L, U6R) (mm) Comparison of surgical accuracy between Planning and Acutual (mm differences) in each group • Description: The distance differences (in millimeters) between the planned 3D position (P3D) and the actual postoperative position (Actual) of each anatomical landmark was measured using voxel-based registration on superimposed preoperative and postoperative CT scans (2 weeks after surgery) using Invivo 7.0 software. Comparison of Surgical Accuracy Between VSP and CSP (mm deviation) • Description: The absolute positional deviations (in mm) of each anatomical landmark were compared between the VSP and CSP groups to assess which surgical planning method yielded higher accuracy
次要结局
未报告次要终点
研究者
Nguyen Phuoc Loi
Principal Investigator, Lecturer of Maxillofacial Surgery Department
University of Medicine and Pharmacy at Ho Chi Minh City