Graftless Technique in Open Maxillary Sinus Lifting Using Poly-Ether-Ether-Ketone Versus Titanium Meshwork for Evaluation of Bone Quantity: Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Bone quantity
研究概览
简要总结
The aim of the study is to assess the amount of bone formation with PEEK (intervention group) in comparison with Titanium Meshwork (control group) in maxillary sinus lifting using CBCT and assessment of the biocompatibility of the Meshwork and PEEK with the schniederian membrane integrity.
详细描述
All patients involved in this study will be divided into two equal groups, each group will be; (Tested group): PEEK after maxillary sinus lifts (Caldwell luc approach). (Control group): Titanium meshwork after maxillary sinus lifts (Caldwell luc approach).
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest and take a primary measurement for the residual bone height of maxillary sinus.
CBCT will be taken in order to design the custom-made PEEK model and its guide of external window before the milling.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height of 3 to 6 mm.
- •Patient age ranges from 25 to 50 years.
- •ASA physical status I and II.
- •Patients willing to be a part of the study and ready to give their consent in writing for the same.
- •Patient not complains from maxillary sinusitis
- •Patients are free from T.M.J disorders, abnormal oral habits such as bruxism.
- •Patient with good oral hygiene.
排除标准
- •• Untreated gingivitis, periodontitis.
- •Subjected to irradiation in the head and neck area less than 1 year before implantation.
- •Untreated periodontitis.
- •Insufficient oral hygiene and motivation.
- •Pregnant or nursing.
- •Bone pathology.
- •Patient with blood disease.
- •Patient with any systematic disease that may affect normal healing.
- •Active infection or severe inflammation in the area intended for implant placement.
- •Treated or under treatment with intravenous amino-bisphosphonates.
研究组 & 干预措施
placement of titanium meshwork after maxillary sinus lifting
placement of titanium meshwork after maxillary sinus lifting
干预措施: titanium meshwork (Device)
placement of PEEK after maxillary sinus lifting
placement of PEEK after maxillary sinus lifting
干预措施: PEEK (Device)
结局指标
主要结局
Bone quantity
时间窗: at 6 months of maxillary sinus lifting
assessment of bone quantity using CBCT
次要结局
- Compatibility with Schneiderian membrane(at 6 months of maxillary sinus lifting)
研究者
mohamed gamal hammad
MSc degree of oral and maxillofacial surgery
Cairo University