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
- 已完成
- 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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 双盲 (受试者、结局评估者)
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.
研究组 & 干预措施
Metal Band and loop
Classic Stainless-steel Band and Loop , Control group
干预措施: stainless steel band and loop (Device)
3d Printed Resin band and loop
3d printed band and loop with the new design , using Permanent Crown resin
干预措施: 3d Printed space maintainer (Device)
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
研究点 (1)
标识符
- NCT 编号
- NCT07161076
- 其他研究编号
- 648/2023, 648/2023
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (8个月前)
- 研究完成日期
- (2个月前)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否