Clinical Evaluation of Digitally Fabricated 3D Printed Palatal Crib Versus Conventional Palatal Crib
Clinical Evaluation of Digitally Fabricated 3D Printed Palatal Crib Versus Conventional Palatal Crib: A Randomized Clinical Trial
The aim of this study is to evaluate clinically digitally fabricated 3d printed palatal crib versus conventional palatal crib
研究概览
地位
详细说明
This study aims to evaluate the clinical performance of a 3D printed palatal crib as an alternative to the conventional palatal crib in managing persistent thumb sucking. The findings may provide evidence on whether digital fabrication offers comparable clinical effectiveness while simplifying the fabrication process and improving appliance customization
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Nourhhan Hamdy, Bachelor degree
- 电话号码:01151201341
- 邮箱:nourhan.hussien@dentistry.cu.edu.eg
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- children aged 6-9 years
- children with persistwnt thumb sucking habit requiring palatal crib therapy
- healthy children (ASA I & II)
- cooperative children whise parents/guardians provide written informed consent and who are willing to attend follow up visits
Exclusion Criteria:
- children with cranifacial anomalies or syndromes ( cleft lip and palate )
- children currently receiving or with a previous history of orthodontic treatment or habit breaking appliance therapy
- children with poor oral hygiene, untreated dental caries, or active periodontal disease requiring treatment before appliance placement
- children with allergies or hypersensitivity to any material used in the appliance
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:3D printed palatal crib
|
A newly digitally fabricated palatal crib 3D printed |
|
有源比较器:Conventional palatal crib
|
A newly digitally fabricated palatal crib 3D printed |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Success rate (habit stop) & patient satisfaction
大体时间:1 year
|
The habit stop during period of time & patient satisfaction using likert facial scale |
1 year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Durability of the device and the bonding
大体时间:1 year
|
1 year
|
合作者和调查者
调查人员
- 学习椅:Adel El Bardissy, PHD、Cairo University
出版物和有用的链接
一般刊物
- Eltager T, Bardissy AE, Abdelgawad F. Cessation of thumb/finger sucking habit in children using electronic habit reminder versus palatal crib: a randomized clinical pilot study. BMC Oral Health. 2025 Jan 6;25(1):27. doi: 10.1186/s12903-024-05310-6.
- Borrie FR, Bearn DR, Innes NP, Iheozor-Ejiofor Z. Interventions for the cessation of non-nutritive sucking habits in children. Cochrane Database Syst Rev. 2015 Mar 31;2015(3):CD008694. doi: 10.1002/14651858.CD008694.pub2.
- Silva M, Manton D. Oral habits--part 1: the dental effects and management of nutritive and non-nutritive sucking. J Dent Child (Chic). 2014 Sep-Dec;81(3):133-9.
- Shams RH, Ali MM, Kabel N, El Khadem AH. Comparing skeletal and dentoalveolar effects of fixed palatal crib and bonded spurs in early management of anterior open bite associated with non-nutritive sucking habits: a randomized clinical trial. Eur Arch Paediatr Dent. 2026 Apr;27(2):439-451. doi: 10.1007/s40368-025-01086-7. Epub 2025 Aug 1.
- Cousley RRJ. In-house three-dimensional printing within the digital orthodontic workflow. J World Fed Orthod. 2022 Dec;11(6):182-189. doi: 10.1016/j.ejwf.2022.10.001. Epub 2022 Nov 5.
- van der Meer WJ, Vissink A, Ren Y. Full 3-dimensional digital workflow for multicomponent dental appliances: A proof of concept. J Am Dent Assoc. 2016 Apr;147(4):288-91. doi: 10.1016/j.adaj.2015.11.018. Epub 2016 Feb 5.
- Yu X, Li J, Yu L, Wang Y, Gong Z, Pan J. A fully digital workflow for the design and manufacture of a class of metal orthodontic appliances. Heliyon. 2024 May 29;10(11):e32064. doi: 10.1016/j.heliyon.2024.e32064. eCollection 2024 Jun 15.
- Cunha TMAD, Barbosa IDS, Palma KK. Orthodontic digital workflow: devices and clinical applications. Dental Press J Orthod. 2021 Dec 15;26(6):e21spe6. doi: 10.1590/2177-6709.26.6.e21spe6. eCollection 2021.
- Panayi NC. In-house three-dimensional designing and printing customized brackets. J World Fed Orthod. 2022 Dec;11(6):190-196. doi: 10.1016/j.ejwf.2022.10.004. Epub 2022 Nov 5.
- Graf S, Vasudavan S, Wilmes B. CAD-CAM design and 3-dimensional printing of mini-implant retained orthodontic appliances. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):877-882. doi: 10.1016/j.ajodo.2018.07.013.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 3D palatal crib vs. old one
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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