Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- peri-implant probing depth
研究概览
简要总结
This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health
详细描述
The aim of this clinical study is to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health regarding the following parameters:
- Modified Plaque index
- Modified Gingival index
- Peri-implant probing pocket depth
Radiographic evaluation (periapical x-ray):
Marginal bone height changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxillary and mandibular alveolar ridges were covered with healthy, firm, relatively even thickness and even compressible mucosa and free from any signs of inflammation or flabbiness.
- •Patients had completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height not less than 15 mm in the interforaminal area and at least 12mm posteriorly
- •All patients had sufficient inter-arch space
- •All patients complained of insufficient retention and stability of their conventional mandibular dentures.
- •All patients were of Angel's class I maxillo-mandibular relationship.
排除标准
- •Patients with absolute contraindications for implant placement, such as active cancer and diseases of the immune system.
- •Patients with metabolic diseases that are directly related to bone resorption, such as uncontrolled diabetes, osteoporosis, and hyperparathyroidism.
- •Patients with general contraindications for surgical procedures, such as hematologic diseases, hepatic patients, patients with bleeding disorders, and serious problems with coagulation.
- •Patients with a history of irradiation of the head and neck region or chemotherapy in the last 3 years were also excluded.
- •Patients with relative contraindications such as a history of parafunctional habits (such as bruxism and clenching), smoking, alcoholism, and patients with any physical reasons that could affect follow-up.
- •Patients with local contraindications for implant placement, such as localized bone defects.
结局指标
主要结局
peri-implant probing depth
时间窗: 1 year
Probing depth using plastic periodontal probe
Peri-implant radiographic evaluation
时间窗: 1 year
Marginal bone height changes using periapical radiograph
peri-implant tissues health (Clinical)
时间窗: 1 year
Modified gingival index
modified plaque index
时间窗: 1 year
peri-implant tissues health (Clinical)
次要结局
未报告次要终点
研究者
Fatma mahanna
lecturer of prosthodontics
Mansoura University