Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- primary stability
研究概览
简要总结
The goal of this clinical trials is to compare two diameters, 1.6 and 2 mm, of mini implants both are 12 mm length placed in the infrazygomatic crest region. The main questions it aims to answer are:
which diameter is more suitable for IZC region 1.6 or 2mm in terms of primary stability, secondary stability, pain perception and failure rate.
20 participant will receive 40 mini implant bilaterally (20 in one side of 1.6mm, the other side 20 of 2mm).
participants will be asked to record visual analog scale (VAS) for 3 nights monitored monthly by the investigator.
详细描述
Using 1.6x12mm and 2x12mm of mini implants in the IZC area and measuring primary stability, secondary stability, failure rate and pain perception.
The primary stability will be measured immediately after insertion using Easycheck device (Dentium, South Korea).
The secondary stability will be measured two months after insertion using the same device.
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion, it will be checked monthly for six months.
pain perception will be recorded by patients using visual analog scale (VAS) score sheet 24 , 48, 72 hour after insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the diameter of the mini-implants placed on each side. The investigator performing the insertion will not be blinded due to the obvious difference in implant diameter.
入排标准
- 年龄范围
- 15 Years 至 38 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged between 15 and 38 years.
- •Patients currently undergoing orthodontic treatment with fixed appliances who require mini-implant placement in the upper buccal posterior region (IZC) for full-arch distalization or en-masse retraction.
- •Patients willing and able to adhere to the study protocol.
- •Recommended for the use of bilateral mini-implants.
排除标准
- •Syndromic conditions, facial trauma, or previous bone-related surgery.
研究组 & 干预措施
1.6 mm
1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.
干预措施: insersion of two diameters of mini implant. (Device)
2 mm
2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.
干预措施: insersion of two diameters of mini implant. (Device)
结局指标
主要结局
primary stability
时间窗: immediately after insertion
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
secondary stability
时间窗: two month after insertion.
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
primary stability
时间窗: immediately after insertion
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
secondary stability
时间窗: two month after insertion.
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
次要结局
- pain perception(after insertion 24 hour, 48 hour, 72 hour.)
- pain perception(after insertion 24 hour, 48 hour, 72 hour.)
- Failure rate(monthly for six months after insertion.)
研究者
Ali Jabbar Al Ameri
student researcher
University of Baghdad