Prosthetic Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Maintenance
研究概览
简要总结
There are two types of complications in implant prosthesis: biologic and prosthetic . Biologic complications refer to disorders in implant function that disturb the supporting peri-implant tissues resulting in mucositis or periimplantitis in severe conditions, the technical complications refer to subjecting the implant, implant parts and /or the superstructures to a damage ,such as screw loosening ,attachment wear, fracture to part of the prosthesis or some of its teeth. Prosthetic complications after the insertion of the final prosthesis may or may not lead to implant loss but lead to an increase demand for repair and maintenance.
This study aimed to assess whether the telescopic overdenture as a removable prosthesis would necessitate maintaince at frequency similar to that with screw retained hybrid overdenture as a fixed prosthesis.
详细描述
Sample size calculation This power analysis used frequency of implant complications as the primary outcome. Based upon the results of Ragheb NA et al (2021) [15];the proportions of complications were 0.407 and 0.037 in the two groups, respectively. Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e., power = 80%; the minimum estimated sample size was 19 implants per group. Sample size was increased to twenty-two implants per group to compensate for a drop-out rate of 30% after two years. Sample size calculation was performed using G*Power Version 3.1.9.2.
Patients were recruited in the study from the Outpatient Clinic of the Prosthodontics Department, Faculty of Dentistry, Cairo University. All of which were dissatisfied from their previous denture experience and seeking better retention to their mandibular denture. Patients had received verbal and written information about the study procedures and a written informed consent was signed prior to participation.
This study is a randomized clinical trial which was approved by the Ethics Committee of Scientific Research of Cairo University.
In this study , all participants had to install four interforaminal implants to receive either telescopic over-denture or screw retained denture.
Before the prosthetic phase, both groups were randomly assigned according to a computerized random allocation program where data of randomization were entered by the secretary of the department who neither participated in recruitment nor in examination procedures.
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
- None
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
- •completely edentulous male patients between the age of 50-70 years. patients with HB=bA1C up to 8 with normal blood sugar (79-110) Sufficient bone width (≥ 6 mm) It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- •Residual bone height ranging from 11-15 mm Patients seeking to install implant and for whom new dentures will be constructed.
- •Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
- •Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
排除标准
- •Any systemic disease that may interfere with dental implants placement and/or Osseointegration as; uncontrolled diabetes, hypertension, osteoporosis and irradiation. Heavy smoker (more than 20 cigarette / day) Patients with parafuctional habits as bruxism and clenching
结局指标
主要结局
Maintenance
时间窗: one year
maintenance for complication assed through counting frequency of incidence
次要结局
未报告次要终点
研究者
Nesma Mohamed awaad
lecturer
Cairo University