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3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.

2026年5月21日 更新者：Murad Alrashidi

3D-Printed Custom Versus Conventional Band-and-Loop Versus Chairside Denovo Space Maintainers in the Primary Dentition: A Randomized Controlled Trial Protocol

Purpose of the Study When a child loses a "baby" molar early due to a cavity or injury, the surrounding teeth can shift into the empty space. This often blocks the permanent adult tooth from growing in correctly. To prevent this, dentists use a small metal device called a space maintainer.

This study aims to find out which of three different types of space maintainers lasts the longest, is most comfortable for the child, and is most efficient for the dental office to provide.

The Three Study Groups

Children in this study are randomly assigned to one of three groups:

  1. 3D-Printed Custom Group: The dentist takes a digital picture (scan) of the child's mouth instead of a traditional mold. A custom-fit appliance is then 3D-printed using a specialized, medical-grade clear material.
  2. Conventional Band-and-Loop Group: This is the traditional method. The dentist takes a physical mold of the teeth, which is sent to a laboratory. The child usually has to return for a second appointment a week later to have the metal appliance glued into place.
  3. Denovo Chairside Group: This uses a kit of pre-made metal parts. The dentist selects the best fit and assembles the appliance right at the chairside, allowing it to be placed during a single visit.

What is Being Measured?

Researchers are following the children for 12 months to track:

Survival: Which appliance stays glued in and doesn't break most effectively?

Time: How much time does the dentist spend making and fitting the appliance?

Comfort: How much discomfort or pain did the child feel during the process?

Health: Does the appliance cause any irritation to the gums or surrounding teeth?

Who Can Participate? The study includes children between the ages of 5 and 10 who have lost at least one primary (baby) molar early and need a space maintainer to protect their future adult smile.

Importance of This Research By comparing these three methods, this study helps dentists understand if newer technologies, like 3D printing or pre-made kits, are better or more convenient than the traditional lab-made metal loops used for decades. This information will help families choose the best treatment for their children.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Clinical Workflow and Device Fabrication

The trial compares three distinct manufacturing and clinical delivery pathways for pediatric space maintenance:

  1. 3D-Printed Custom Workflow (Experimental Arm)

    Data Acquisition: Digital impressions are captured using a high-precision intraoral scanner (3Shape TRIOS).

    Design Phase: The STL files are imported into CAD software (exocad), where a custom space maintainer is designed with a specific focus on anatomical adaptation to the abutment tooth and the edentulous ridge.

    Manufacturing: Appliances are fabricated via Stereolithography (SLA) using a Form 3B+ printer with BioMed Clear Resin. Post-processing includes a 20-minute isopropyl alcohol wash and 60 minutes of UV curing at 60°C to ensure biocompatibility and optimal mechanical properties.

    Delivery: The printed appliance is bonded using a light-cured orthodontic adhesive.

  2. Conventional Band-and-Loop Workflow (Active Comparator)

    Clinical Phase: Traditional alginate impressions are taken and poured with dental stone to create a physical working model.

    Laboratory Phase: A stainless steel band (3M Unitek) is fitted to the abutment tooth on the model. A 0.036-inch stainless steel wire is contoured to the ridge and silver-soldered to the band.

    Delivery: The appliance is polished and cemented in a subsequent clinical appointment using glass ionomer cement.

  3. Denovo Chairside Workflow (Active Comparator)

Selection: A prefabricated kit (Denovo Dental) is used to select a band size that fits the abutment tooth.

Assembly: A pre-formed wire loop is selected and adjusted for length at the chairside. The loop is mechanically secured to the band using the system's specialized crimping and locking mechanism, eliminating the need for soldering or laboratory delays.

Delivery: The assembled appliance is cemented during the same appointment as the initial measurement.

Randomization and Standardization Participants are allocated 1:1:1 using a computer-generated randomization sequence. To ensure consistency, all clinical procedures-including tooth preparation, scanning, and cementation-are performed by a group of calibrated pediatric dentists following a standardized protocol. For the 3D-printed group, resin batches and printer calibration are monitored weekly to ensure material integrity.

研究类型

介入性

注册 (估计的)

360

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

  • 姓名：MURAD A ALRASHIDI, Pediatric Orthodontist
  • 电话号码：+966 55 302 2773
  • 邮箱：MU.ALRASHIDI@qu.edu.sa

学习地点

  • 沙特阿拉伯
    • Al-Qassim Region
      • Buraidah、Al-Qassim Region、沙特阿拉伯、52571
        • Qassim University
        • 接触：

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

是的

描述

Inclusion Criteria:

  1. Children aged 5 to 10 years
  2. Premature unilateral loss of at least one primary first or second molar
  3. Radiographically confirmed developing permanent successor at Nolla developmental stage 4 to 7
  4. Parent or legal guardian able and willing to provide written informed consent, and child able to provide age-appropriate assent

Exclusion Criteria:

  1. Systemic disease affecting bone metabolism or tooth development
  2. Clinically significant mesiodistal space loss at screening, defined as greater than 3 mm
  3. Poor oral hygiene precluding band placement, defined as a full-mouth plaque score greater than 50%
  4. Known allergy or hypersensitivity to stainless steel or resin components
  5. Current participation in another interventional clinical trial

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：3D-Printed Custom Space Maintainer
Participants in this arm receive a custom-designed space maintainer fabricated through a fully digital workflow. This involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The appliance is 3D-printed using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin, a biocompatible photopolymer. The appliance is bonded to the abutment tooth using a light-cured orthodontic adhesive during a single or subsequent clinical visit.
设备：3D-Printed Custom Space Maintainer
A digitally designed, monolithic space maintainer. The workflow involves an intraoral scan (3Shape TRIOS) and CAD design (exocad). The device is fabricated using stereolithography (SLA) technology (Formlabs Form 3B+) with BioMed Clear Resin. It is bonded to the abutment tooth using a light-cured orthodontic adhesive
有源比较器：Conventional Band-and-Loop
This arm represents the current clinical reference standard. Fabrication follows a traditional analog workflow beginning with an alginate impression and stone model. A stainless steel band (3M Unitek) is fitted to the model, and a stainless steel wire (0.036-inch) is hand-contoured and silver-soldered to the band. The completed appliance is polished and cemented using glass ionomer cement in a second clinical appointment.
设备：Conventional Band-and-Loop Space Maintainer
The traditional clinical reference standard. It is fabricated using an analog workflow: an alginate impression is taken to create a stone model, a stainless steel band (3M Unitek) is fitted to the model, and a 0.036-inch stainless steel wire is hand-contoured and silver-soldered to the band. The appliance is polished and cemented with glass ionomer cement.
有源比较器：Denovo Chairside Space Maintainer
This arm utilizes a prefabricated, chairside system (Denovo Dental) designed for single-visit delivery. A pre-sized stainless steel band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is then adjusted for the appropriate span and mechanically secured to the band using a specialized crimping and locking tool, eliminating the need for laboratory soldering. The appliance is cemented during the same appointment as the initial fitting.
设备：Denovo Chairside Space Maintainer
A prefabricated, stainless steel space maintainer system (Denovo Dental) designed for immediate application. A pre-sized band is selected and fitted directly to the patient's tooth. A pre-formed wire loop is adjusted for length at the chairside and mechanically secured to the band using a specialized crimping and locking tool, requiring no laboratory soldering. It is cemented during the initial appointment.

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
Appliance Survival Rate
大体时间：At 12 months from baseline
This measures the clinical longevity and "success" of the appliance. A "failure" is recorded if the appliance becomes completely or partially dislodged (cement failure), suffers a structural fracture, or causes significant soft-tissue trauma requiring its removal.
At 12 months from baseline
Space Maintenance Effectiveness:
大体时间：At 12 month from baseline
Measured as the change in the mesiodistal dimension of the extraction space (in millimeters). Digital calipers or software will compare the initial space at baseline to the space remaining at the end of the study.
At 12 month from baseline

次要结果测量

结果测量
措施说明
大体时间
Clinical and Laboratory Time (Efficiency)
大体时间：At baseline
Researchers will record the active working time (in minutes) for each stage of fabrication. This includes chairside time (scanning or impressions and fitting) and laboratory time (3D printing and post-processing, manual soldering, or chairside assembly).
At baseline
Gingival Health (Löe and Silness Index):
大体时间：Baseline, at 6 months, and at 12 months.
A clinical assessment of the soft tissue surrounding the abutment tooth. It will be scored from 0 (normal) to 3 (severe inflammation/bleeding) to determine if any material or design causes more irritation than others.
Baseline, at 6 months, and at 12 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

Murad Alrashidi

调查人员

  • 首席研究员：MURAD ALRASHIDI, BDS, MSC、Qassim University

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 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26-20-3

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The investigators will share the de-identified individual participant data that underlie the results reported in the final publication. This includes primary survival data (time-to-failure), gingival index scores, and recorded fabrication times.

IPD 共享时间框架

Data will become available 6 months after the primary manuscript is published in a peer-reviewed journal.

IPD 共享访问标准

Data will be made available to qualified academic researchers. For researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal (e.g., meta-analysis or validation of digital orthodontic workflows). Data requestors must sign a formal Data Access Agreement to ensure the privacy of the pediatric participants. Requests should be directed to the Principal Investigator.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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

是的

在美国制造并从美国出口的产品

是的

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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