Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Clinical Success Rate of Space Maintainers
研究概览
简要总结
The goal of this study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are:
- What is the clinical success rate of 3D printed space maintainers compared to traditional metal band and loop space maintainers over a 12-month period?
- How do 3D printed space maintainers compare in maintaining space and preventing rotation of abutment teeth?
- What are the differences in gingival health outcomes between the two types of space maintainers?
Participants (13 children aged 6-9 years) will:
Receive both devices in a "split-mouth" design (one on each side of the mouth), totaling 26 treated tooth spaces (13 per group).
Attend checkups every 3 months for a year to monitor the devices' performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy children.
- •Children of both genders aged 6-9 years old.
- •Guardians agree to join the study and sign the informed consent.
- •Recent premature loss of primary first molars or having primary first molars indicated for extraction on both sides.
- •Sound buccal and lingual surfaces of abutment teeth (primary second molar and primary canine).
- •Good oral hygiene.
- •Absence of radiographic periapical pathology related to the abutment teeth.
- •Absence of abnormal occlusal conditions such as posterior crossbite, deep bite, and scissor bite.
- •All the indications for a band and loop space maintainer are met.
排除标准
- •The patient is not able to attend regular follow-up visits.
- •Allergic condition to any of the used materials.
结局指标
主要结局
Clinical Success Rate of Space Maintainers
时间窗: 12 months
Percentage of space maintainers remaining functional without failure Unit of Measure: Percentage of participants
Gingival health index
时间窗: at 3-month follow-up, 6 months follow-up , and 1 year follow-up
measuring Gingival index for both space maintainers to compare the a ability of plaque to attach to both devices. scale 0-3, higher scores indicate worse gingival health
次要结局
- Wong-Baker FACES Pain Rating Scale(immediately after cementation,at 3-month follow-up)
研究者
Omar hodhod
Assistant lecturer of pediatric dentistry
British University In Egypt