Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible by Using Fully Versus Semi Guided Prototyped Surgical Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Radio graphic evaluation (Angular deviation)
研究概览
简要总结
Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.
详细描述
Objectives: Current study aimed to assess the accuracy of fully- guided implant placement in completely lower edentulous patients compared to the semi-guided protocol.
Materials and Methods
Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants. Measurements and analysis of results were performed by means of a software tool used during virtual planning (P3Dental; Protótipos).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Dental professionals who were not informed about the group assignments carried out the assignment and randomization of patients to the treatment groups.
入排标准
- 年龄范围
- 58 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patient wearing maxillary conventional denture.
- •All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
- •They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- •All patients are of angel's class I maxillo-mandibular relationships.
排除标准
- •Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- •Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
- •Long term immunosuppress and corticosteroid drug therapy.
- •Patient with abnormal habits as clenching and bruxism.
- •Smoking patient.
- •Patient with problems in TMJ
研究组 & 干预措施
fully guided surgical technique
The guides were designed with metal sleeves for guided drilling and guided implant placement and additional guide sleeves for the stabilization of the template by fixation screws.The implant width and length were selected for each patient according to previous 3d cone beam, and the drills of this kit were 11 mm longer than conventional drills. The surgery was performed without flap elevation. The guide was seated and fixed by means of 2-mm cortical screws in the buccal region after using of the corresponding drills.
干预措施: fully guided stent (Device)
semi guided surgical technique
The guides were designed with metal sleeves for guided drilling and guided implant placement and additional guide sleeves for the stabilization of the template by fixation screws.The implant width and length were selected for each patient according to previous 3d cone beam, and the drills of this kit were 11 mm longer than conventional drills.The surgery was performed without flap elevation. The stent was removed before the final drilling
干预措施: semiguided stent (Device)
结局指标
主要结局
Radio graphic evaluation (Angular deviation)
时间窗: one year
For both groups, postoperative CBCT scan was performed after implant placement. The same parameters of preoperative CBCT were followed according to the patient's position, image acquisition, and use of the same apparatus. This scan was performed with the same dental prosthesis as that used for the initial preoperative CBCT scanning, equipped with the gutta percha references, for superimposition of the images. The previously fabricated occlusal registration was used to align the prosthesis. Both CBCT scans were superimposed, and the software compared preoperative horizontal (Mesiodistal and buccolingual), vertical and angular virtual measurements of planned implants with real measurements of the placed implants.
次要结局
- Radio graphic evaluation (linear deviation)(one year)