3D Printed Clear Aligners for Microbial Colonization

Overseen By Rendy Fernandez, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Periodontal disease, Craniofacial anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different types of clear aligners, including new 3D-printed ones, collect bacteria. The goal is to determine whether 3D-printed aligners harbor more or less bacteria than traditional ones. Individuals with all their adult teeth, who do not smoke, and are not undergoing other orthodontic work may be suitable candidates. This trial aims to enhance the design of clear aligners, making them safer and cleaner. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to safer dental products.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dental health and aligners, so it's best to ask the trial coordinators for more details.

What prior data suggests that these aligners are safe for assessing microbial colonization?

Research shows that 3D printed clear aligners, such as TA-28 and TC-85, are generally safe, though some concerns exist. Studies on TA-28 indicate that the material is very accurate and safe for making aligners, but there are worries about potential chemical leakage. Despite this, aligners made from TA-28 are considered safe overall.

For TC-85, research highlights its good antibacterial properties, which help reduce bacteria. However, it may be slightly more toxic to cells compared to other aligners. While this might sound concerning, it does not imply harm when used as directed. TC-85 aligners also exhibited some color changes, affecting appearance rather than safety.

Both aligners have approval for other orthodontic uses, suggesting safety for people. The main concerns involve slight chemical release and cell toxicity, so discussing any questions or concerns with the trial team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 3D printed clear aligners, TA-28 and TC-85, because they offer a novel approach to reducing microbial colonization. Traditional aligners are usually thermoformed, but these new aligners are 3D printed, which allows for more precise customization to each patient's dental structure. This precision may lead to a better fit, potentially reducing areas where bacteria can gather and thrive. Additionally, the 3D printing process could offer more rapid production and easier adjustments compared to conventional methods. By exploring these innovative features, researchers hope to improve oral hygiene and overall aligner effectiveness.

What evidence suggests that this trial's aligners could be effective for reducing microbial colonization?

This trial will compare different types of clear aligners, including 3D printed aligners TA-28 and TC-85, as well as a thermoformed clear aligner. Research has shown that 3D printed aligners, like TA-28, may offer advantages over traditional aligners due to a special process that ensures their safety. TC-85 is recognized for its strong antibacterial properties, which could reduce infection risk. These directly printed aligners are promising because they can be customized and might fit teeth better. Although more research is needed, early results suggest these 3D printed aligners could effectively straighten teeth that are mildly to moderately misaligned. ^{1 2 3 6 7}

Who Is on the Research Team?

Aron Aliaga del Castillo, DDS, MS, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals using orthodontic clear aligners. It's designed to see if there's a difference in bacterial buildup between standard thermoformed and two types of 3D printed aligners. Participants must be eligible for orthodontic treatment with clear aligners, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am not currently receiving any orthodontic treatment.

Participants are in the permanent dentition

Participants can understand written English instructions

Exclusion Criteria

Severe tooth crowding

I have had gum disease or issues with the structure of my face and jaw.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear different types of clear aligners to assess microbial colonization

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Patient Perception Assessment

Participants complete a survey to assess their perception of the clear aligners

Approximately 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D printed clear aligner TA-28
• 3D printed clear aligner TC-85

Trial Overview The study compares traditional thermoformed clear aligners with two kinds of 3D printed ones (TC-85 and TA-28) to check which one has more bacteria on it over time. These materials are usually used for moving teeth, but now they're being tested just to see how much bacteria grow on them.

How Is the Trial Designed?

Group I: Thermoformed clear aligner Experimental Treatment 3 Interventions

Results compiled for this aligner from all orders of aligner assignments.

Group II: 3D printed clear aligner TC-85 Experimental Treatment 3 Interventions

Results compiled for this aligner from all orders of aligner assignments.

Group III: 3D printed clear aligner TA-28 Experimental Treatment 3 Interventions

Results compiled for this aligner from all orders of aligner assignments.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. withpower.com withpower.com/trial/phase-orthodontic-aligner-7-2025-811b8

3D Printed Clear Aligners for Microbial Colonization This study is being done to compare conventional clear aligners with 3D printed clear aligners to assess if there is any significant difference between the ...

2. nature.com nature.com/articles/s41598-025-85359-7

Biocompatibility of variable thicknesses of a novel directly ... The standard 20-minute UV curing protocol ensures the biocompatibility and patient safety of Tera Harz TA-28 for material thicknesses up to 6 mm.

3. mdpi.com mdpi.com/2076-3417/14/22/10084

3D Printed Orthodontic Aligners—A Scoping Review This scoping review aims to provide a comprehensive summary of the current literature on 3D-printed orthodontic aligners.

4. app.trialscreen.org app.trialscreen.org/trials/microbial-colonization-three-dimensional-3d-printed-orthodontic-clear-trial-nct07143370

Microbial Colonization in Three Dimensional (3D) Printed ... A comparative study of microbial colonization in 3D printed vs conventional orthodontic clear aligners ... treatment safety and effectiveness for future patients.

5. researchgate.net researchgate.net/publication/394943742_Effects_of_directly_printed_aligner_eluent_on_the_viability_and_transcriptome_of_gingival_fibroblasts

Effects of directly printed aligner eluent on the viability and ... Direct printed aligners (DPAs) offer benefits like the ability to vary layer thickness within a single DPA and to 3D print custom-made removable ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12112703/

Do Clear Aligners Release Toxic Chemicals? Our results suggest that clear aligners are generally safe, but concerns remain regarding the chemical leaching of thermoplastic materials, bacterial ...

7. nature.com nature.com/articles/s41598-025-14004-0

Enhanced anti-microbial properties of clear aligner resin ... It has been reported that directly 3D printed clear aligners generate more consistent and lighter force which enable optimal force application ...