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Clinical Performance of Direct-Printed Versus Thermoformed Aligners

2026年6月5日 更新者：Ali Rahman Issa、University of Baghdad

Clinical Performance of In-Office Directly Printed Versus Thermoformed Aligners: A Randomized Clinical Trial

The goal of this study is to evaluate and compare the clinical effectiveness of in-office directly 3D-printed clear aligners versus conventional multilayered thermoformed aligners.

The main question it aims to answer is:

Does the use of in-office direct-printed shape-memory aligners result in superior clinical effectiveness, compared to established multilayer thermoformed aligner systems?

Researchers will compare a Direct-Printed Aligner (DPA) group using Senertek Clear-A V2 resin to a Thermoformed Aligner (TFA) group using Zendura FLX multilayer sheets to see if the additive manufacturing process improves clinical outcomes and patient satisfaction.

Participants will:

  • Undergo initial records including intraoral digital scans, photos, and a panoramic radiograph for treatment planning.
  • Wear their assigned clear aligners (either direct-printed or thermoformed) for at least 22 hours per day, changing them every 7 days.
  • Attend follow-up appointments every 5 weeks.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a prospective, parallel-arm randomized controlled multi-center clinical trial, to assess and compare the clinical effectiveness of in-office 3D-printed clear aligners with multilayered thermoformed aligners.

The subject population for this study will be male and female subjects aged 16-30 years who have fully erupted permanent dentition and mild dental crowding or spacing.

Methodology:

Patients requiring orthodontic treatment are randomly allocated into two groups.

Experimental Group (DPA): Aligners are fabricated using additive manufacturing (direct 3D printing) with Senertek Clear-A V2 shape-memory resin. This process eliminates the intermediate physical model, potentially reducing cumulative manufacturing errors.

Control Group (TFA): Aligners are fabricated by thermoforming multilayered thermoplastic sheets (Zendura FLX) over 3D-printed resin molds.

Assessment:

Digital models (STL files) will be obtained at the start (T0) and at the end of the treatment (T1). These will be compared to the digital treatment plan (Tp) using 3D superimposition and trigonometric analysis. Stable anatomical structures, such as the palatal rugae, will serve as reference points for superimposition. The primary outcome is the "Tracking Accuracy Percentage," which measures how closely the actual clinical tooth movement matches the digitally predicted movement. Secondary outcomes include clinical efficiency, patient-reported pain levels, and Manufacturing complexity, including total fabrication time.

研究类型

介入性

注册 (估计的)

34

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、10013
      • Baghdad、伊拉克、10047
        • 招聘中
        • Orthodontic department, College of dentistry, university of Baghdad.
        • 接触：
    • Bab Al-Muadham
      • Baghdad、Bab Al-Muadham、伊拉克、10047

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
  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Adult patient with an age range of 15-30 with fully erupted all permanent dentitions excluding third molars, and a willingness to participate in the trial.
  2. Angle Class I non-extraction cases, presented with mild crowding or spacing (<5 mm) and dental rotation <30° .
  3. Good oral hygiene; no active caries/periodontal disease, no history of trauma or root resorption.

Exclusion Criteria:

  1. Pregnancy, smoking, and systemic conditions affecting bone remodeling.
  2. Subject with poor oral hygiene, using simplified oral hygiene index (OHI-S ≥ 3.1 ) (Greene & Vermillion, 1963).
  3. Patient with malposed lower second molars (need orthodontic alignment).
  4. Allergy to materials used (resins, plastics, solvents).
  5. History of trauma, root resorption, and dilacerated roots.
  6. Previous extraction or history of previous orthodontic treatment.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Direct-Printed Aligner
Participants in this group will receive clear aligners manufactured using in-office 3D printing technology. This arm tests the effectiveness of additive manufacturing and the shape-memory properties of the resin in achieving programmed tooth movements.
设备：Direct-Printed Aligner
Participants in this group will receive clear aligner therapy fabricated via direct-printing, utilizing a specialized light-curable resin (Clear-A V2, Senertek, İzmir, Turkey).
有源比较器：Thermoformed Aligner
Participants in this group will receive conventional clear aligners manufactured using the vacuum-forming (thermoforming) process. This arm serves as the gold standard to which the experimental 3D-printed aligners are compared.
设备：Thermoformed aligner
Participants in this group will treated with clear aligners fabricated via the conventional indirect method, involving the thermoforming of thermoplastic sheets (Zendura FLX, Zendura dental, Fremont, California) over 3D-printed dental molds.

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
Angular tooth movement tracking accuracy
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Digital models (Initial (T0), planned (Tp), and final (T1)) will be compared using trigonometry. Angular measurements of vestibulo-lingual tipping, mesio-distal tipping, and rotation, will be performed on the three digital casts that had been previously superimposed.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Linear tooth movement tracking accuracy
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Evaluation of the tracking accuracy of linear tooth movements (in millimeters) by superimposing three-dimensional digital dental models across three therapeutic stages: Initial (T0), Planned (Tp), and Final (T1). Trigonometric spatial analysis will be executed on the superimposed digital casts to quantify the absolute positional discrepancy between the virtually planned tooth position and the actual clinically achieved position.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.

次要结果测量

结果测量
措施说明
大体时间
Clinical efficiency
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
The additional treatment time necessitated by refinements will be calculated and compared statistically between the study groups.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Evaluate degree of conversion
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
The relative concentration of unreacted aliphatic carbon double bonds will be evaluated by measuring the peak areas of the aliphatic C=C stretching vibrations (at 1634 cm -1 and 1620 cm-1) and the stable internal standard (N-H bending absorption at 1523 cm-1) via the tangent baseline technique. These distinct spectral values will be mathematically aggregated using the standard normalized ratio equation: DC (%)=[1-(R cured/R monomer)]×100. Unit of Measure, percentage (%) of converted double bonds.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Shape memory property
大体时间：3 months
The percentage of shape recovery over time and the total deformation angles exhibited by both the direct-printed resin (Senertek Clear-A V2) and the thermoformed aligner sheets.Quantitative measurements will be recorded using a standardized thermo-mechanical bending test layout under controlled temperature intervals.
3 months
Color stability assessment
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Optical transmittance will be measured across the visible light spectrum to evaluate and compare the transparency degradation and color stability of direct-printed versus thermoformed aligners before and after in vivo aging.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Manufacturing complexity and fabrication time
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
For each workflow, the total production time, hands-on labor, and material expenses will be recorded and analyzed.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Patient-Reported Treatment Discomfort
大体时间：The expected duration of subject participation from enrollment to the end of treatment is 6-12 months.
Patient-reported pain or discomfort evaluated on a standard horizontal Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain). Unit of Measure, millimeters (mm) on a 100 mm scale.
The expected duration of subject participation from enrollment to the end of treatment is 6-12 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

University of Baghdad

调查人员

  • 研究主任：Noor Muhammed Garma, Assistant Professor、University of Baghdad, College of Dentistry, Department of Orthodontic.

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9月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年5月23日

首先提交符合 QC 标准的

2026年6月5日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年6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

  • 1197426

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

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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