The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patients With Labial Alveolar Ridge Defect and Simultaneous Implantation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans
研究概览
简要总结
Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation.
详细描述
Because adequate bone wrapping around the implant is critical for long-term effectiveness of dental implant treatment, bone augmentation in the bone defect area is required to repair the width and height of the alveolar bone, as bone resorption occurs following tooth extraction.
Many bone augmentation techniques, such as onlay block grafting, bone splitting, distraction osteogenesis, and guided bone regeneration, are currently accessible in clinics (GBR). Surgical options vary depending on the severity of the bone deformity. GBR is a bone augmentation technique that has more evidence-based medicine support and therapeutic applications, as well as the benefits of less surgical stress and low technical sensitivity.
Establishing aesthetics and guaranteeing long-term success in implant therapy can be challenging. Long-term stable implant success has been linked to the presence of more than 2mm labial graft thickness, and appropriate labial graft thickness is essential to preserve crestal bone level and prevent marginal soft tissue recession. According to a meta-analysis of 15 randomized-controlled trials, the estimated mean (SD) bone resorption for GBR in lateral ridge augmentation throughout the 6-month healing period was 1.22-0.28 mm. As a result, a 3.5 mm thickness of labial graft at all levels may be necessary following wound closure to compensate for potential graft loss.
Traditional bone augmentation is often dependent on the operator's skill, therefore virtually digital guided bone regeneration (GBR) process offers the digital options for precise and controllable bone augmentation in the field of oral implantology .
Specific aim: to compare the contour of bone augmentation (peri-implant bone volume) between various (GBR) procedures in patients with lateral alveolar ridge defect and simultaneous implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
each patient will be couded and only the princeiple investigator is the only person how know the type of intervantion
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients between the ages of 18 and 65 with edentulous ridge and seek for implant replacement.
- •In the anterior region, there is a labial bone defect.
- •Patients need the surgery in the first place to compensate for bone loss around implant.
排除标准
- •Systemic disorders that are out of control.
- •Heavy smokers (those who smoke more than 20 per day).
- •Women who are pregnant or nursing.
- •Thin gingival bio-type.
研究组 & 干预措施
control
The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied [conventional guided tissue regeneration].
干预措施: conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation (Procedure)
study
The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied which consist of a two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour.
干预措施: 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation (Procedure)
结局指标
主要结局
Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans
时间窗: baseline, immediately after and 6 months after surgery
The postoperative CBCT DICOM images were converted to STL files and overlaid over the preoperative CBCT.The thickness of the labial bone graft was measured from the labial outline of the bone graft to the implant as a result of the procedure. (T0-T5) Perpendicular to the simulated implant in the bucco-oral cross-sectional picture. The distance (width in millimeter) between the implant and the labial contour of the graft, which indicated the thickness of the labial bone graft, was measured at the implant shoulder (T0), as well as at 1, 2, 3, 4, and 5 mm apical to the implant shoulder (T1-T5). For each site, the standard deviation of T0, T1, and T2 (SDC) was calculated, which represents the uniformity of the graft contour in the coronal area.
次要结局
未报告次要终点