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3D Printed Reverse Twin Block for Class III Malocclusion (3DRTB)

2026年7月19日 更新者：Linda Basim、University of Baghdad

Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial

This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.

primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 伊拉克
      • Baghdad、伊拉克
        • 招聘中
        • Collage of Dentistry, University of Baghdad

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  1. The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
  2. Presence of permanent first molar with lower anterior teeth to retain the appliance.

  3. Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.

    b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2.

  4. Prescence of unilateral or bilateral posterior crossbite.
  5. Mild to moderate anterior crowding.
  6. Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -

Exclusion Criteria:

  1. Patients with cleft lip and palate and/or craniofacial anomalies.
  2. History of previous orthopedic and/or orthodontic treatment.
  3. Presence of uncontrolled systemic disease or medically compromised status.
  4. Uncooperative patient/parents.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：3D printed Reverse Twin Block appliance
patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin.
设备：3D printed Reverse Twin Block appliance
a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
有源比较器：Conventional Reverse Twin Block appliance
patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin.
设备：Conventional Reverse Twin Block appliance
a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion

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
Changes in sagittal relation using lateral cephalometric radiograph.
大体时间：T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees. 2. SNB angle in degrees. 3. ANB angle in degrees. 4. Wits appraisal in degrees. 5. SN-Pog angle
T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment

次要结果测量

结果测量
措施说明
大体时间
Transverse relationship by Study model
大体时间：T0 baseline records T1 after 3 months T2 after 6 months

This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2.

  1. Intermolar width: which is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars.
  2. Arch length: Arch length will be achieved by measuring the summation of right and left lines that passing through the midpoint between the distal surfaces of the deciduous second molar or the first permanent molar to the midpoint between the central incisors.
T0 baseline records T1 after 3 months T2 after 6 months

其他结果措施

结果测量
措施说明
大体时间
Oral hygiene index-children (OHI-C) will be measured
大体时间：T0 baseline record T1 after 3 months T2 after 6 months

The six index teeth that will be included:

  1. 16/55: Maxillary right permanent first molar or maxillary right primary second molar.
  2. 11/51: Maxillary right permanent central incisor or maxillary right primary central incisor.
  3. 26/65: Maxillary left permanent first molar or maxillary left primary second molar.
  4. 36/75: Mandibular left permanent first molar or mandibular left primary second molar.
  5. 31/71: Mandibular left permanent central incisor or mandibular left primary central incisor.
  6. 46/85: Mandibular right permanent first molar or mandibular right primary second molar.
T0 baseline record T1 after 3 months T2 after 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Baghdad

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月10日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年7月14日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月19日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1213426

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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