Effect Of Occlusal Materials Used For All On Four Implant Supported Mandibular Fixed Prosthesis With PEEK Framework
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- occlusal stability
研究概览
简要总结
This study was performed to compare between the effects of different occlusal materials used for all on four implant supported mandibular fixed prosthesis with PEEK framework.
Methods of Evaluation
1- Occlusal force analysis using digital occlusal device (occluscan).
The evaluation periods will be done at time of insertion (T0),6 month (T1),12 month(T2) and 18 month(T3) after framework insertion.
详细描述
thirty completely edentulous patients will be selected for the study from the outpatient's clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
The patients will be selected according to the following criteria:
- lack of satisfaction of mandibular conventional dentures due to denture instability.
- Atrophy of mandibular ridges with insufficient bone.
- They were healthy, free from any systemic diseases relating to bone resorption.
- All patients have sufficient inter-arch space >15 mm.
- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.
- Normal maxilla-mandibular relationship (class I Angle's classification).
- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT.
- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.
Exclusion criteria included:
1- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
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 (Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •1- lack of satisfaction of mandibular conventional dentures due to denture instability. 2- Atrophy of mandibular ridges with insufficient bone. 3- They were healthy, free from any systemic diseases relating to bone resorption. 4- All patients have sufficient inter-arch space >15 mm. 5- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility. 6- Normal maxilla-mandibular relationship (class I Angle's classification). 7- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT. 8- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.
排除标准
- •1- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis). 2- Local or general contraindication for surgical procedures. 3- History of chemotherapy or radiation therapy to the head and neck area. 4- Habits as heavy smoking and alcoholism. 5- Patients with T.M.J disorders or poor neuromuscular co-ordination.
结局指标
主要结局
occlusal stability
时间窗: The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion
Occlusal stability using digital occlusal device (occlusense)
次要结局
未报告次要终点
研究者
Mohamed shady
Assistant Professor
Mansoura University