3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .
详细描述
A- Intervention Group (Patient specific PEEK sheets)
- Preoperative Computed tomography will be done to the patients.
- Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.
- Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.
- After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.
- Wounds closure will be done.
- CT scan will be done postoperative.
- After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.
B- Control Group (Autogenous bone shell technique)
- Preoperative Computed tomography will be done to the patients
- Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.
- The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1
- The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.
- Wounds closure will be done.
- CT scan will be done.
- After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.
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
- None
盲法说明
None because the two interventions requires different preoperative preparations , both the participants and the investigator can't be blinded .
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
- 否
入选标准
- •Adult patients with deficient alveolar bone in the anterior maxilla.
- •Patient seeking fixed prosthesis at the anterior maxillary region.
- •Highly motivated patients.
- •Good oral hygiene.
- •Patients willing for the surgical procedure and follow-up, with an informed consent.
- •Bounded anterior maxilla cases.
排除标准
- •Medically compromised patients.
- •Uncooperative patients.
- •Poor oral hygiene.
- •Periodontal diseases.
- •No history of any grafting procedure at the designated edentulous ridge.Criteria
- •Patients with any diseases that compromise bone or soft tissue healing.
- •Patients with no local pathosis that interfere with the bone healing.
研究组 & 干预措施
Patient specific PEEK sheets
Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge .
干预措施: Patient specific PEEK sheets (Procedure)
Autogenous bone shell technique
Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge .
干预措施: Autogenous bone shell (Procedure)
结局指标
主要结局
Patient satisfaction
时间窗: 8 months
Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)
次要结局
- Bone quality(4-6 months post-operative)
- Bone gain(4-6 months post-operative)
- Soft tissue reaction(4-6 months postoperative)
- Intraoperative time(Intraoperative)
研究者
Ola Alaa El-Din Abd El-Monem Mohamed
Principle Investigator
Cairo University