Albumin Platelet-Rich Fibrin in Lateral Sinus Floor Augmentation With Simultaneous Implant Placement: A Prospective Two-Year Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. implant stability
研究概览
简要总结
thirty-two implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patent ostium of maxillary sinus.
- •Patient with missing one or more posterior maxillary teeth.
- •Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
- •A ridge width at the site of implantation of <5mm.
- •Platelets of normal range.
- •Good oral hygiene.
- •Patients in the age frame between 20 years and 60 years old.
- •No gender preface in selection of the patients.
- •A minimum crown height space of 8 mm.
排除标准
- •Active sinusitis, cyst, tumors or root tips at the planned surgical site.
- •Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- •Heavy smoking and alcoholism.
- •Parafunctional habits such as bruxism and clenching.
- •Signs of acute infection or pus discharge.
- •Disturbed occlusion.
研究组 & 干预措施
lateral sinus lift with bone augmenation
干预措施: lateral sinus lift with using allograft and pericardium membrane (Procedure)
lateral sinus lift with extended platelet rich fibrin
干预措施: lateral sinus lift with using exteneded platelet rich fibrin (Procedure)
结局指标
主要结局
1. implant stability
时间窗: 12 months
the stability of the implants will be evaluated by RFA with the Osstell Mentor device.
2. Vertical bone height
时间窗: 24 Months
vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant
次要结局
未报告次要终点
研究者
Ammar Radwan
postgraduate student
Mansoura University