Patient Satisfaction and Oral Health-Related Quality of Life of Quadrilateral Versus Bilateral Linear Bar Designs for Four Implant Implant-Assisted Complete Mandibular Overdenture Regarding Peri-Implant Crestal Bone Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- marginal bone loss
研究概览
简要总结
For this study, twenty patients were selected, and participants were randomly divided into two groups using random numbers produced in an Excel spreadsheet. Each patient got four implants in the mandibular canine and first molar sites, as well as the bar attachment.
The purpose of this study was to document and report patient satisfaction with mandibular implant overdentures with quadrilateral distribution and linear distribution. The null hypothesis was that patient satisfaction would not be different depending on the distribution type (quadrilateral or linear).
According to the bar design, all patients were classified into two equal groups: quadrilateral bar design (group I) and bilateral linear bar design (group II). Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have Angle's class I maxilla-mandibular relation
- •sufficient inter-arch space
- •a healthy, firm mucosa,
- •enough residual alveolar ridges in the mandibular regions to support implants
排除标准
- •neuromuscular disorder,
- •excessive smoking,
- •alcoholism,
- •parafunctional habits
- •systemic disorders affecting the bones
- •history of head and neck radiation therapy.
研究组 & 干预措施
group 1 quadrilateral bar design
Quadrilateral Group: each participant received bar mandibular overdentures on 4 implants with quadrilateral distribution. A plastic ready-made bar was cast in cobalt chrome alloy.
干预措施: Implant (Other)
group2 : Bilateral linear bar
Bilateral linear Group: each participant received bar mandibular overdentures on 4 implant on bilateral configuration
干预措施: Implant (Other)
结局指标
主要结局
marginal bone loss
时间窗: Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.
Patient Satisfaction
时间窗: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
次要结局
未报告次要终点
研究者
Heba Wageh Abozaed Elsaed Mansour
Principal Investigator
Mansoura University