Prosthetic Maintenance Assessment for Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Framework: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Evaluation of Prosthetic Maintenance of both types of implant retained overdentures
研究概览
简要总结
The goal of this randomized clinical trial is to compare and assess the prosthetic maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr frameworks after twelve months. Twenty-four participants were randomly assigned to two groups: Group I received a mandibular implant-retained overdenture reinforced with a Co-Cr framework, while Group II received a mandibular implant-retained overdenture reinforced with a PEKK framework. Also, both groups were rehabilitated with a maxillary complete removable denture.
详细描述
Twenty-four participants with edentulous maxillary and mandibular ridges underwent meticulous selection, with two implants placed in the mandibular canine areas through a two-stage surgical technique facilitated by a radiographic and surgical stent. Following this, patients were provided with maxillary and mandibular complete removable dentures relined with soft liners. After the subsequent three-month osseointegration period, ball attachments were introduced. Patients were randomly allocated to two groups based on the type of prosthesis they received. Group I received mandibular implant-retained overdenture reinforced with the Co-Cr framework, while Group II received mandibular implant-retained overdenture reinforced with the PEKK framework, both groups received complete removable dentures for the maxillary arch. The assessment of prosthetic maintenance for mandibular implant-retained overdentures in both groups was conducted twelve months post-denture insertion.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age range between 50-70 years old.
- •Completely edentulous patients
- •Systemically free from any disease that contraindicates implant placement.
- •A minimum of 12 -15 millimeters of bone height and 6 mm bone width at canine areas diagnosed from the pre-operative cone beam CT.
- •Sufficient inter-arch space (15mm) to accommodate the mandibular implant-retained overdentures.
排除标准
- •Patients with bone or mucosal diseases.
- •Heavy smokers.
- •Patients with uncontrolled metabolic disorders such as diabetes mellitus.
- •Patients with parafunctional habits.
- •Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.
结局指标
主要结局
Evaluation of Prosthetic Maintenance of both types of implant retained overdentures
时间窗: twelve months after delivery of implant retained overdenture
Evaluation of prosthetic maintenance for mandibular implant-retained overdentures in both groups was made after twelve months of overdenture insertion. Prosthetic maintenance is a checklist for the following aspects that were inspected regarding screw (screw loosening, screw fracture), attachments (wear, distortion, fracture, replacement), and overdentures (reline, remake, fracture, teeth wear, teeth separation, or fracture).maintenance for complication assed through counting frequency of incidence. The unit of measurement used is percentage.
次要结局
未报告次要终点
研究者
Omnia M Refai
Lecturer of Oral and Maxillofacial Prosthodontics
Ain Shams University