Application of Virtual Surgical Planning in Mandibular Segmental Resection With Reconstruction Plate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Accuracy of Occlusion after surgery following virtual surgical planning
研究概览
简要总结
Purpose: Odontogenic tumors, predominantly affecting the mandibular region, pose significant challenges in terms of treatment planning, particularly when requiring segmental mandibular resection. This study aims to evaluate the effectiveness of virtual planning and 3D modeling in comparison to traditional surgical methods for treating mandibular odontogenic tumors, focusing on aspects such as accuracy, clinical outcomes, and patient quality of life.
Method: The study is designed as a two-phase investigation. Phase 1 involves in vitro research to create high-precision 3D models and surgical support instruments. Phase 2 consists of a clinical trial with two groups: the Virtual Surgery Group using pre-bent reconstruction plates, 3D mandibular models and surgical guides and the Conventional Surgery Group. Data collection includes assessing model accuracy, comparing clinical outcomes, analyzing postoperative CT scans, and evaluating patient quality of life.
Expected Results: Investigators anticipate that the virtual planning and 3D modeling approach will yield more accurate surgical procedures, improved postoperative outcomes, and enhanced patient quality of life compared to traditional methods. This is expected to be particularly beneficial in maintaining the stability of the condyle at the postoperative site, reducing complications related to mandibular function, and potentially reducing the need for additional surgeries.
Conclusions: If the investigators study demonstrates the superiority of virtual planning and 3D modeling in treating mandibular odontogenic tumors, it could significantly impact the field of oral and maxillofacial surgery by offering a more precise and effective treatment approach. This could ultimately lead to improved patient outcomes and a reduction in the challenges associated with these complex surgical procedures.
详细描述
Introduction:
Odontogenic tumors predominantly affect the mandibular region, constituting approximately 99.1% of all benign tumors in the jawbone. Among these, odontogenic tumors, largely associated with teeth, account for a significant portion. Notably, in the mandibular bone make up 67.7% of all odontogenic tumors in the facial jaw region. Furthermore, benign odontogenic tumors of the mandible often exhibit slow progression, typically devoid of pain, and primarily manifest as bony swelling. As a result, tumors are often detected at later stages, potentially leading to severe complications such as complete mandibular destruction, facial deformities, malocclusion, and, in rare cases, malignant transformation.
The management of benign odontogenic tumors of the mandible remains a subject of debate and challenge. The ideal treatment approach must involve an appropriate level of bone resection while minimizing recurrence, thereby ensuring both aesthetic outcomes and functional restoration in the oral region. Two surgical methods are commonly employed: conservative approaches such as enucleation, curettage, with or without peripheral ostectomy, and radical surgical resection involving segmental bone removal. Segmental mandibular resection is chosen when tumors exhibit extensive bone destruction and do not respond to conservative treatments, particularly in cases of highly invasive tumors with less than 1 cm of remaining bone thickness beneath the lower mandible border.
Although segmental resection achieves high treatment efficacy with a low recurrence rate, it is an invasive approach associated with postoperative anatomical complications. Maintaining the correct alignment of the mandibular condyle within the glenoid fossa after segmental resection is a significant challenge. The natural articulation of the condyle and fossa plays a crucial role in mandibular function. Maintaining the original condylar position after resection remains challenging, leading to issues related to temporomandibular joint (TMJ) function, including joint clicking, pain, and limited mouth opening. Failure to address these issues promptly can result in severe complications such as ankylosis and dislocation, necessitating additional corrective surgery. Therefore, preserving the natural condylar-glenoid fossa relationship is crucial, and it requires special attention. Moreover, accurate alignment of the reconstructed segment with the desired orientation is essential.
With the advent of virtual surgical planning based on 3D modeling and 3D printing technology, tools to aid in the reconstruction of the mandible after segmental resection can be designed and manufactured before surgery, potentially yielding improved postoperative outcomes. The decision to perform immediate reconstruction with bone grafting simultaneously during segmental mandibular resection presents a significant challenge. While this approach may reduce the need for subsequent surgeries and shorten functional recovery time, it remains controversial due to the invasiveness and the strong likelihood of local tumor recurrence. Additionally, this technique may be unsuitable for large tumors or those diagnosed at a late stage. In such cases, grafting becomes challenging, especially when the extent of bone loss in the mandible exceeds 6 cm. Consequently, vascularized bone grafting is an option; however, it is associated with high costs and technical difficulties, limiting its accessibility to many patients. Therefore, segmental mandibular resection combined with reconstruction plate placement remains an effective method for treating benign mandibular odontogenic tumors, reducing the risk of recurrence, and ensuring treatment options for the majority of patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients indicated for mandibular segment resection and reconstruction plate placement.
- •Patients in overall good health suitable for undergoing anesthesia.
- •Patients who consent to the surgery and agree to participate in the study.
排除标准
- •Patients indicated for temporomandibular joint dislocation due to invasive tumor.
- •Patients with infections in the mandible.
- •Patients with a history of trauma or surgery in the concave region of the mandible.
- •Patients with contraindications for surgery due to systemic diseases.
- •Patients without the conditions for postoperative follow-up and re-examination.
结局指标
主要结局
The Accuracy of Occlusion after surgery following virtual surgical planning
时间窗: Baseline, 1 week, 24 weeks
Assessment by Clinical Assessment involves observing three areas: the front teeth region, the right posterior teeth region, and the left posterior teeth region. The scoring scale is as follows: Posterior teeth group: Achieving interlocking: 2 points, achieving contact: 1 point, completely open: 0 points. Anterior teeth group achieving contact: 1 point, completely open: 0 points. Calculate the total score attained and classify the bite joint based on the criteria: Good: ≥ 4, Average: 2 - 3, Poor: \< 2
The Accuracy of Condylar position after surgery following virtual surgical planning
时间窗: Baseline, 1 week, 24 weeks
Assessment by CT scan the condylar position after surgery following the change anatomical lankmarks. Value of Condylar Deviation: The range between -12% to +12% is Center position, The range +12% is Forward position, and the range \< -12% is Rearward position
次要结局
未报告次要终点
研究者
Le Hoai Phuc
Principal Investigator Le Hoai Phuc
University of Medicine and Pharmacy at Ho Chi Minh City
