Comparative Assessment For The Positional Accuracy Of Dental Implants Inserted By Computerized Stackable Surgical Guides Made From Selective Laser Melting And Digital Light Processing Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- global angel deviation and global linear coronal and apical deviation in mm.
研究概览
简要总结
Purpose; The purpose of this research is to make a comparative estimation for the positional accuracy of dental implants inserted by selective laser melting and digital light processed computerized stackable surgical guides for patients with maxillary terminal dentitions.
Materials and methods; Twenty-four dental implants will be installed in partially edentulous patients who will be applied for treatment of tooth loss and required fixed prosthodontic rehabilitation. Virtually designed prosthetically driven fixation base with its stackable surgical osteotomy guide will be used for bone reduction after tooth extraction and osteotomy preparation respectively. The inserted implants will be divided equally into two groups according to stackable surgical osteotomy guide to either selective laser melting (SLM) CO-Cr metal or digital light processing (DLP) surgical-guides. The final actual implant position will be compared to the preoperative planned position and the deviations will be calculated for coronal deviation, apical deviation in mm, and two angular deviation measurements in degrees.
详细描述
Preoperative evaluation:
intra-oral and extra-oral examination and medical history for each patient will be recorded to assure that the patient will be eligible for the research.
Written informed consent will be assigned by the patients who will be included in the study.
Preoperative records Polyvinyl siloxane (PVS) impressions for both arches will be made. Also, an interocclusal record will be recorded.
The poured upper and lower cast will be mounted on the articulator and will be scanned using a tabletop scanner (DOF swing, DOF, Korea). the scanned file will be saved in stl format Clinical digital photographs for digital smile design will be used to generate a smile design driven by an individual's face and smile display. As such, it is critical to have at least two portraits representing the lips at rest and another one for a broad smile For each patient, a preoperative cone beam computed tomography (CBCT) scan with the two jaws separated via cotton rolls to separate the volume of interest using a CBCT machine (Scanora 3Dx, Soredex- Finland ) will be taken and saved as Digital Imaging and Communication in Medicine (DICOM) files. The saved STL files will be imported into computer-aided design (CAD) software ( Implastation, prodigident, USA) and superimpose these files to the DICOM files and the JPEG photo files.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •well healthy patients
- •patients with maxillary terminal dentition
排除标准
- •Patients with, systemic disease that might complicate post-operative healing or contribute to bone resorption
- •patients with parafunctional habits, poor oral hygiene, limited mouth opening, severe alveolar bone deficiencies,
- •patients with uncontrolled diabetes, current irradiation to the head or neck, psychological disorders, or alcohol, tobacco, or drug abuse
结局指标
主要结局
global angel deviation and global linear coronal and apical deviation in mm.
时间窗: 1 weekk
patients will be submitted to a CBCT scan using the same parameter as the preoperative scan. And the data of the postoperative scan will be superimposed over the preoperative plan to assess the accuracy of the implant placement using the software (blueskybio 4, BlueSky bio, USA). The final actual implant position will be compared to the preoperatively planned position and the deviations will be calculated for global angel deviation and global linear coronal and apical deviation in mm.
次要结局
未报告次要终点