The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture: Clinical Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overdenture retention assessed using Universal Testing Machine (Newton)
研究概览
简要总结
This study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Completely edentulous.
- •Age: 50-60 years.
- •Free from any systemic diseases that affect bone metabolism.
- •Good intraoral condition.
- •Anterior mandibular bone height > 13mm and width > 5mm.
- •The inter-arch space from 15mm to 17mm.
排除标准
- •Smoking and drug abusing.
- •Severe maxillomandibular skeletal discrepancy.
- •Bone metabolic disorders.
- •History of head and neck radiotherapy.
- •Intravenous bisphosphonate therapy.
- •Presence of para-functional habits.
- •Temporomandibular joint disorders.
- •Severe bony undercuts.
研究组 & 干预措施
PEEK clip
Clip for overdenture retention made from poly-ether-ether-ketone (PEEK)
干预措施: PEEK clip (Device)
Nylon clip
Clip for overdenture retention made from nylon (C6H11NO)n
干预措施: Nylon clip (Device)
结局指标
主要结局
Overdenture retention assessed using Universal Testing Machine (Newton)
时间窗: From enrollment and after 3 months and finally at the end of treatment at 6 months
Denture resistance corresponding to vertical displacement force was obtained using a universal testing machine (INSTRON, United States) to measure retention. Each patient had his chin securely fixed on a support while seated upright. The attachment portion of the universal machine was adjusted in accordance with the device's bar being securely attached to the denture. The device gradually increased the vertical load by 10 mm per minute until the denture completely fell out of place. A tuck sound can be heard to indicate the load at the dislodgment point. Additionally, the force plot in the recorded computer software data exhibits an abrupt drop (Nexyge; Lloyd Instruments; MT-4.6). Each test was repeated five times to obtain five records, and the mean of these records was calculated. Testing was carried out on the mandibular overdenture after insertion, as well as at 3 and 6 months.
次要结局
未报告次要终点
研究者
Sara Medhat Mohamed Ali
Lecturer of Removable Prosthodontics
MTI University