Evaluation of the Accuracy of Three-Dimensionally Guided Zygomatic Implant Placement: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- implant success.
研究概览
简要总结
This study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. A prospective non-controlled clinical study was performed on ten patients with compromised zygomaticomaxillary bone. Surgical intervention was carried out using a customized surgical guide.
Pre-surgical planning was performed using computed tomography (CT) scans for each patient. Surgical guides were fabricated using direct metal laser sintering technology. Zygomatic implants were inserted using a guided surgical protocol and specialized instruments.
Postoperative CT scans were obtained to evaluate deviations between the planned and actual implant positions. Accuracy was assessed by superimposing the postoperative implant position onto the virtual pre-surgical implant plan using dedicated software. Descriptive and bivariate statistical analyses were performed.
详细描述
Purpose: The aim of this study was to evaluate the accuracy of using a static surgical guide protocol for zygomatic implant placement in patients with compromised zygomaticomaxillary bone.
Materials and methods: All the patients had a pre-operative initial consultation interview with the surgeons mainly for collecting demographic data, taking general medical, surgical, and dental history, and listening to the patient's esthetic complaints and postoperative expectations.
- A pre-operative multiplanar CT scan of the face to evaluate residual maxillary bone, zygomatic bone, and sinus condition to detect any sinus pathology. This gives initial data about the orientation of the zygomatic implant (ZI), positioning, angulation, and length using 3D planning software.
- The resulting DICOM files were segmented, forming STL (Standard Triangulation Language) files that were used as a baseline for post-operative superimposition.
- Under general anesthesia, patients underwent either contralateral nasal intubation to the working side or oral intubation.
- A palatal paracrestal incision was carried out in the maxillary soft tissues with vertical posterior releasing incisions.
- The muco-periosteal flap was elevated to expose the alveolar crest, the piriform aperture, the lateral wall of the maxillary sinus if present, the infraorbital nerve emergence, the maxillary tuberosity, and the central and the posterior part of the zygomatic bone.
- The surgical guide was fitted in its position and fixed with cortical screws. Implant osteotomy was performed. Then zygomatic implants were inserted.
- The wound was irrigated with normal saline and debridement of the surgical field before suturing using Vicryl 3/0.
Post-operative assessment:
All patients were regularly followed up on the 7th & 14th days postoperatively to assess the following parameters:
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lack of maxillary posterior bone in which standard implants are impossible to insert.
- •2. Post-surgical maxillary defects with limitations of maxillary bone reconstruction due to lack of soft tissue coverage.
- •3. Failure of previous reconstructive procedures.
排除标准
- •Opportunity of alternative treatment modalities with bone grafting and standard implants.
- •Any relevant systemic or local diseases that might affect the bone healing, like uncontrolled diabetic patients or cancer patients who are still on chemotherapy or previously received radiation on the head and neck region.
研究组 & 干预措施
Single-arm interventional study
Patients received zygomatic implants using a customized bone-supported surgical guide following three-dimensional preoperative planning.
干预措施: zygomatic implant installation using custamized bone supported surgical guide (Procedure)
结局指标
主要结局
implant success.
时间窗: 3 months
Implant success was assessed based on clinical stability and osseointegration. Stability was evaluated using torque testing during implant uncovering with a torque value of 10-20 Ncm applied to the multiunit abutment screw without implant rotation.
Implant survival
时间窗: 1 year
Implant survival was assessed based on the absence of implant mobility, pain, infection, peri-implant inflammation, suppuration, and progressive bone loss.
Coronal Deviation
时间窗: 1 week
Deviation at the coronal entry point of the implant between the planned implant position and the actual postoperative implant position measured using three-dimensional superimposition of preoperative planning and postoperative CT scans.
Apical Deviation
时间窗: 1 week
Linear deviation at the apical endpoint of the implant between the planned implant position and the postoperative implant position measured using three-dimensional image superimposition.
Angular Deviation
时间窗: 1 week
Angular deviation between the long axis of the planned implant and the postoperative implant measured in degrees using 3D software analysis.
Soft tissue wound healing:
时间窗: 4 weeks
Postoperative clinical evaluation of the surgical site including signs of inflammation, infection, or intraoral wound dehiscence.
次要结局
- Prosthetic Survival(1 year)
- Oral Health Impact Profile (OHIP-14)(1 year)
研究者
Eslam Abd elhaliem Gharieb
Assistant lecturer of oral and maxillofacial surgery department
Tanta University