Effect of Using Polyetherketoneketone (PEKK) Framework Versus Cobalt Chromium Framework on The Supporting Structures of Mandibular Implant Supported Hybrid Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- amount of bone loss around implant
研究概览
简要总结
the purposse of the study To evaluate the effect of implant supported hybrid prostheses on the bone of the supporting structure of edentulous mandible using Polyetherketoneketone (PEKK) framework versus cobalt chromium framework. fourteen female patients with lower single edentulous ridges are chosen with adequate dental hygiene, enough interarch space and free of systemic diseases and parafunctional habits. Patients who received new single dentures are randomly allocated into each group using computer software program and five intraforaminal implants were inserted parallel using surgical guide.
详细描述
Patient's approval:
- All patients will be informed in details about the nature of the investigation and the aim of the study. They will agree to take part in the study and will sign on an informed consent form.
- All participants will be given notice about their privacy practices, their legal duties and their rights.
- In case of implant treatment failure, the patients will receive a new well-fitting denture.
Patient's grouping:
In this study there will be two equal groups, grouping will be based on the material that will be used for framework construction:
Group I: framework will be fabricated using PEKK. Group II: frame work will be fabricated using cobalt chromium alloy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
all the selected patients were rehabilitated with lower single denture then divided by computer randomization using random allocation software
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient's age range from 50 to 60 year's old.
- •All patients are with completely edentulous mandible.
- •Good oral hygiene is mandatory.
- •Sufficient interarch space to accept implant supported fixed prosthesis will be diagnosed by mounted diagnostic casts.
- •Firm and healthy mucosa covering the alveolar ridge.
- •Minimum bone width 5.5mm buccolinguallly and 10 mm height will be diagnosed by the preoperative cone beam CT scan.
排除标准
- •- Vulnerable group; prisoners, mentally, physically disabled, pregnant females.
- •Patients with Para functional habits.
- •Patients having TMJ disorders.
- •Uncontrolled diabetic patients
- •Patients have any medical condition or any disease that could interfere with implant placement or affect bone loss.
结局指标
主要结局
amount of bone loss around implant
时间窗: 2 years
The points of first bone contact with the fixture platform were detected and changes of those points position through the two years of observation were registered as a criterion of bone changes with further calculation of average values. A software ruler of CBCT was used to measure the crestal bone height in contact with the implant from the four aspects (buccal, lingual, mesial and distal).
次要结局
未报告次要终点