Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to final dental rehabilitation
研究概览
简要总结
Immediate reconstruction and dental rehabilitation of maxillofacial ablative defects with patient specific reconstruction plates, dental implants, and immediate load provisional screw-retained prosthesis will improve patient short and long term outcomes and improve patient quality of life. Utilizing current technologic advances, patients undergoing large ablative procedures for benign head and neck pathology can now not only have immediate bone and soft tissue reconstruction, but dental rehabilitation as well. Using virtual surgical planning, patient specific selective laser melded reconstruction plates, and dental implants, a screw-retained provisional dental restoration can be fabricated and placed during a one-stage procedure with minimal to no intra-operative prosthetic work required.
详细描述
The primary goal of any reconstructive procedure is to restore a patient's natural form and function. The new techniques implemented in this study will demonstrate an approach that allows immediate return of the patient's premorbid state in one procedure. The investigators have demonstrated success with a small cohort of patients, and published a recent case study regarding this new technique. This study is meant to build upon the investigators experiences and advance their process and treatment of these patients. With a larger patient population to study, greater data can be obtained, with the ultimate goal of establishing this treatment as a new standard of care for patients with large ablative defects requiring reconstruction.
Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study. All of the patients will undergo the following pre-operative protocol:
- CT Maxillofacial Region
- CTA
- Dental impression (intra-oral scan and/or impressions)
- Virtual surgical planning
- Patient specific plate fabrication
- Resection and flap harvest osteotomy guides
- Fabrication of screw-retained provisional prosthesis
Surgical treatment protocol involves:
- Resection of benign tumor using osteotomy guides
- Reconstruction with free tissue (osseous free flap) transfer using osteotomy guides
- Placement of dental implants (minimum of three) using integrated osteotomy and implant placement guide
- Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply)
- Inset of flap/implant/prosthesis/custom plate construct
- Vascular anastomosis and closure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients between 16 and 60 years of age
- •Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study.
排除标准
- •Patients below the age of 16 years and over the age of 60 years
- •Patients with malignant tumors
- •Patients with contraindications for surgical intervention and/or free tissue transfer
- •Patients actively participating in another investigational clinical study and who, in the Investigator's or opinion, should not be enrolled in this study.
研究组 & 干预措施
Reconstruction and Dental Rehabilitation
Placement of NobelActive dental implants (minimum of three) using integrated osteotomy and implant placement guide.Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply). Inset of flap/implant/prosthesis/custom plate construct (KLS Martin Mandibular Reconstruction Implant).
干预措施: NobelActive (Device)
Reconstruction and Dental Rehabilitation
Placement of NobelActive dental implants (minimum of three) using integrated osteotomy and implant placement guide.Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply). Inset of flap/implant/prosthesis/custom plate construct (KLS Martin Mandibular Reconstruction Implant).
干预措施: KLS Martin Mandibular Reconstruction Implant (Device)
结局指标
主要结局
Time to final dental rehabilitation
时间窗: 6-8 months
Time elapsed until final dental rehabilitation is reached.
次要结局
- Surgical outcome accuracy (CT imaging)(5-10 days post-op)
- Total operating room time(6-8 hours)
- Implant survival - Short term(6 months post operatively)
- Implant survival - Long term(one year post operatively)