跳至主要内容
临床试验/NCT05405179
NCT05405179招募中不适用

Simultaneous Dental Implant in Free Vascularized Bone Flaps for Jaw Reconstruction Using Patient-specific Surgical Guides and Titanium Plates: a Pilot Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Intraoperative success rate

研究概览

简要总结

After jaw resection, free vascularized bone flaps are frequently used for repairing maxillofacial defects. Simultaneous dental implantation is more preferable to secondary implantation as it saves the patients from going through a second surgery after recovering from the first one.

In this study, the aim is to preliminarily evaluate the clinical outcome of simultaneous dental implants in vascularized bone flaps in jaw reconstruction using patient-specific surgical plates and 3-in-1-PSSG. The objectives of this study were: 1) to investigate the intraoperative success rate; 2) to measure the accuracy of dental implants position; and 3) to assess implant survival rate and postoperative adverse events.

详细描述

After jaw resection, free vascularized bone flaps are frequently used for repairing maxillofacial defects. Owing to the extensive loss of dentition and soft tissues after the ablative surgery, the use of conventional fixed and removable prostheses is often limited in such cases. Implant-supported fixed prosthesis could be a better alternative which is free-standing and does not rely on tooth or soft tissue support. Dental implants on bone flaps restore the patient's oral function and comfort. Simultaneous dental implantation is more preferable to secondary implantation as it saves the patients from going through a second surgery after recovering from the first one.

However, conventional freehand immediate placement of dental implants in jaw reconstructive surgery is technically challenging as the position has to be highly precise to support an aesthetic and functional prosthesis. The current development of computer-aided surgery has been able to plan the inset of a vascularized bone flap in the maxillomandibular complex using digitally planned and printed surgical guides based on the patient's computed tomography (CT) data. The computer-aided surgery also facilitates the placement of dental implants at the optimal position and the modification of the bony reconstruction according to the implant position. Previously, the investigators have designed and fabricated novel patient-specific surgical plates by metal three- dimensional (3D) printing technology for jaw reconstruction, which led to precise reconstructive outcomes. In this study, the investigators propose a novel three-in-one patient-specific surgical guide (3-in-1-PSSG) which includes bone segmentation, surgical plate and implant placement positioning functions, to facilitate simultaneous dental implants in vascularized bone flap jaw reconstruction. It is hypothesized that the 3-in-1-PSSG simplifies the surgical procedure. Together with the patient-specific titanium plate, the clinical outcomes for simultaneous dental implants in jaw reconstruction with vascularized bone flap will be improved.

In this study, the aim is to preliminarily evaluate the clinical outcome of simultaneous dental implants in vascularized bone flaps in jaw reconstruction using patient-specific surgical plates and 3-in-1-PSSG. The objectives of this study were: 1) to investigate the intraoperative success rate; 2) to measure the accuracy of dental implants position; and 3) to assess implant survival rate and postoperative adverse events.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age greater than 18 years, of both gender;
  • •Diagnosed with maxillofacial benign or malignant pathology and indicated for jaw surgery with immediate dental implants;
  • •Titanium plates and dental implants will be used in the surgery;
  • •Agree to comply with follow-up procedures;
  • •Provision of signed and dated informed consent form.

排除标准

  • •Patients who are pregnant;
  • •Patients who need jaw reconstruction for the management of post-traumatic, congenital or developmental jaw deformities;
  • •Patients who have medically compromised conditions and cannot tolerate the surgery;
  • •Patients who are unable to have a two-week period prior to surgery, for virtual surgery simulation, patient-specific plates designing and fabrication;
  • •Patients whose systemic conditions or diseases that violate the normal bone healing;
  • •Patients who are unable to take the preoperative and postoperative CT/CBCT scans.

研究组 & 干预措施

Simultaneous dental implantation

Experimental

To perform dental implantation simultaneously in free vascularized flap during jaw reconstruction

干预措施: Simultaneous dental implantation (Procedure)

结局指标

主要结局

Intraoperative success rate

时间窗: Intraoperative

Success is defined as the uneventful placement of dental implant with adequate stability and correct angulation (Implant insertion torque value greater than 15Ncm and no implant thread exposure)

次要结局

  • Accuracy of dental implant placements(One month after surgery)
  • Implant survival(6 months after surgery)
  • Impact of oral health condition on quality of life(6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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