Peri-Implant Bone Changes Associated With Internal Tri-Lobe Versus Internal Hexagonal Implant-Abutment Connections in Immediately Loaded Mandibular Overdentures: A One-Year CBCT Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Peri-Implant Crestal Bone Height
研究概览
简要总结
Objective: Compare changes in crestal bone height and peri-implant bone density using cone-beam computed tomography (CBCT) at baseline, 6 months, and 12 months post-placement.
Participants & Setup: 14 fully edentulous male patients (aged 45-60) received two mandibular canine implants. Comparison Groups: Group I (n = 7) received internal tri-lobe implants (ReActive System), and Group II (n = 7) received internal hexagonal implants (Legacy II System).
Intervention: Implants were immediately loaded with ball attachments to retain lower overdentures.
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
- 45 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 45-60 years who are completely edentulous in both arches; presentation of a normal ridge relationship with D2 bone quality and Type A or B bone quantity; provision of written informed consent.
排除标准
- •Systemic conditions affecting bone metabolism; heavy smoking; poorly controlled diabetes; history of radiotherapy or chemotherapy.
研究组 & 干预措施
Internal Tri-Lobe Connection
Patients fitted with the ReActive Implant System (internal tri-lobe platform).
干预措施: ReActive Implant System (Internal Tri-Lobe Platform) (Device)
Internal Hexagonal Connection
Patients fitted with the Legacy II Implant System (internal hexagonal platform).
干预措施: Legacy II Implant System (Internal Hexagonal Platform) (Device)
结局指标
主要结局
Change in Peri-Implant Crestal Bone Height
时间窗: Baseline (implant placement), 6 months, and 12 months
次要结局
- Change in Peri-Implant Bone Density(Baseline (implant placement), 6 months, and 12 months)
研究者
Rania Zaarour
Dr
Gulf Medical University