Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Postoperative Pain (Visual Analog Scale, VAS)
研究概览
简要总结
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS)
详细描述
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS). Pre and Post Operative CBCT Will be taken. Bone density will be assessed Using 3D onDemand Softwear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with hopeless teeth at maxillary esthetic zone.
- •Both genders.
- •Middle age adults (from 20 years to 55 years).
- •The tooth to be extracted had little to no loss of periodontal bone.
- •The tooth where endodontic involvement, root fracture, root resorption, periapical pathology, root perforation
排除标准
- •1-Medically compromised patient (uncontrolled diabetes, radiotherapy, chemotherapy and hemophilia.
- •2-Patient with bad oral habit as bruxism, heavy smoking over 10 cigarettes a day.
- •3-Patient with bad oral hygiene. 4-Patient with generalized gingival diseases. 5-Patient with generalized periodontal diseases [with sever vertical or horizontal bone loss] 6-Teeth with periapical or lateral acute infection or lesions.
研究组 & 干预措施
Study group : immediate implants placement with deproteinized bovine bone augmentation
8 hopeless teeth was replaced by immediate dental implants with deproteinized bovine bone augmentation
干预措施: Immediate dental implants with bone graft augmentation (deproteinized bovine bone) (Device)
Control group : Implant implants Placement without bone augmentation
8 hopeless teeth was replaced by immediate dental implants without bone augmentation
干预措施: Immediate dental implants without bone augmentation (Device)
结局指标
主要结局
Postoperative Pain (Visual Analog Scale, VAS)
时间窗: 1, 3, and 7 days postoperatively
Patients reported the degree of pain using a 10-cm visual analog scale (VAS), where 0 = no pain and 10 = worst possible pain. Pain was assessed at 1, 3, and 7 days postoperatively.
Visual Scale of Edema
时间窗: 1, 3, and 7 days postoperatively
Facial edema was assessed using a visual grading scale: No edema, Low-grade, Intermediate-grade, and High-grade, based on visual inspection and palpation. Edema was evaluated at 1, 3, and 7 days postoperatively.
Implant Stability (ISQ)
时间窗: Baseline (immediately after implant placement) and 6 months postoperatively
Clinical stability of dental implants was assessed using the Osstell device. The implant stability quotient (ISQ) was measured immediately after implant placement and at 6 months postoperatively. ISQ scores range from 1-100, with scores ≥70 indicating high stability, 60-69 medium stability, and \<60 low stability.
Peri-implant Bone Density
时间窗: Baseline (immediately after implant placement) and 6 months postoperatively
Bone density around the implants was measured using CBCT radiographs and analyzed with 3D OnDemand software. Measurements were recorded immediately postoperatively and at 6 months.
次要结局
未报告次要终点