Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Bone gain
研究概览
简要总结
10 Patients having horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment.
Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately.
Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample.
- •Patients who already gave their consent for this trial.
- •Males and females both will be included.
排除标准
- •Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study.
- •Subjected to irradiation in the head and neck region within the last year
- •Patients allergic to drugs used in the study like ( Articaine, Lidocaine,
- •Patients having a history of a major medical condition (ASA 3,4)
- •Untreated periodontitis.
- •Poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnant or nursing.
- •Substance abuse.
- •Psychiatric problems or unrealistic expectations.
- •Severe bruxism or clenching.
- •Immunosuppressed or immunocompromised.
- •Treated or under treatment with intravenous amino-bisphosphonates.
- •Active infection or severe inflammation in the area intended for implant placement.
- •Unable to open mouth sufficiently to accommodate the surgical tooling.
- •Patients participating in other studies, if the present protocol could not be properly followed.
- •Referred only for implant placement or unable to attend a 5-year follow-up.
结局指标
主要结局
Bone gain
时间窗: T0 before surgery, T1 immediately after surgery and T2 after 6 months
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm
次要结局
- Bone Quality(0 before surgery, T1 immediately after surgery and T2 after 6 months)
- Accuracy of Plan Transfer(1-3 days postoperatively)
- Clinically successful osseointegrated implant(At the day of the surgery and 6 months after first surgery)
研究者
Mohamed Mahmoud Samy Bahgat
Principal Investigator
Cairo University