Orthodontic AlignerNCT07143370
Microbial Colonization in Three Dimensional (3D) Printed Orthodontic Clear Aligners
A study testing Thermoformed clear aligner, 3D printed clear aligner TC-85 and 3D printed clear aligner TA-28 in people with Orthodontic Aligner and Microbial Colonization, run by University of Michigan at 1 site in United States.
Trial summary
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 microbial colonization of these appliances. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Aligner, Microbial Colonization
- What is being tested?
- Thermoformed clear aligner, 3D printed clear aligner TC-85 and 3D printed clear aligner TA-28
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are in the permanent dentition
- Participants can understand written English instructions
- Participants have no history of smoking
- Participants will not undergo any active orthodontic treatment.
Who cannot join
- Periodontal disease/gingivitis or craniofacial anomalies.
- Severe tooth crowding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbial Colonization in 3D Printed Orthodontic Clear Aligners
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 microbial colonization of these appliances. The 3D printed aligner material and conventional aligner materials are being used for investigational purposes and have been approved for their use in fabricating clear aligners for orthodontic tooth movement, but not for the purposes of our study, which is for the fabrication of clear passive aligners to assess microbial colonization.
- Conditions
- Orthodontic Aligner, Microbial Colonization
- Being tested
- Thermoformed clear aligner, 3D printed clear aligner TC-85, 3D printed clear aligner TA-28
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoformed clear alignerDevice
All participants will receive a thermoformed aligner fabricated from polyethylene terephthalate glycol (PETG) material. This aligner is made from using an intraoral scan to print a 3D model of their maxillary dentition, that is then used for the thermoforming process. This aligner will be worn 20-22 hrs/day for 1 week.
3D printed clear aligner TC-85Device
All participants will receive a 3D printed aligner fabricated from TC-85 resin. This aligner will be made using an Stereolithography (STL) file from their intraoral scan to design the clear aligner and then will be fabricated using the SprintRay Pro 95 S printer. This aligner will be worn 20-22 hrs/day for 1 week.
3D printed clear aligner TA-28Device
All participants will receive a 3D printed aligner fabricated from TA-28 resin. This aligner will be made using an STL file from their intraoral scan to design the clear aligner and then will be fabricated using the SprintRay Pro 95 S printer. This aligner will be worn 20-22 hrs/day for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed clear aligner TC-85 | Experimental | Results compiled for this aligner from all orders of aligner assignments. Receives: Device: Thermoformed clear aligner; Device: 3D printed clear aligner TC-85; Device: 3D printed clear aligner TA-28 |
| 3D printed clear aligner TA-28 | Experimental | Results compiled for this aligner from all orders of aligner assignments. Receives: Device: Thermoformed clear aligner; Device: 3D printed clear aligner TC-85; Device: 3D printed clear aligner TA-28 |
| Thermoformed clear aligner | Experimental | Results compiled for this aligner from all orders of aligner assignments. Receives: Device: Thermoformed clear aligner; Device: 3D printed clear aligner TC-85; Device: 3D printed clear aligner TA-28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial colonization of the tooth surface
Assessed using a swab to the tooth surface (three times, once for each aligner)
Measured: 1 week Immediately following aligner wear
Microbial composition of inner surface biofilm of aligners
Assessed using a swab of the inside of each aligner (three times, once for each aligner)
Measured: 1 week Immediately following aligner wear
Secondary outcomes (1)
Patient perception of clear aligners
Assessed using a 11 question survey (9 questions use a likert like scale of 0(poor)-10(excellent))
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start2 Sep 2025
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic AlignerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aron Aliaga del Castillo, University of Michigan
- Investigators
- Aron Aliaga del Castillo, DDS, MS, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143370
- Sponsor's protocol ID
- HUM00268846
- Status last verified
- Nov 2025
- First submitted
- 7 Aug 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Colonization in 3D Printed Orthodontic Clear Aligners
- ClinicalTrials.gov ID
- NCT07143370
- Acronym / sponsor ID
- HUM00268846
- Conditions
- Orthodontic Aligner, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 microbial colonization of these appliances. The 3D printed aligner material and conventional aligner materials are being used for investigational purposes and have been approved for their use in fabricating clear aligners for orthodontic tooth movement, but not for the purposes of our study, which is for the fabrication of clear passive aligners to assess microbial colonization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3D printed clear aligner TC-85 | Experimental | Device: Thermoformed clear aligner, Device: 3D printed clear aligner TC-85, Device: 3D printed clear aligner TA-28Results compiled for this aligner from all orders of aligner assignments. |
| 3D printed clear aligner TA-28 | Experimental | Device: Thermoformed clear aligner, Device: 3D printed clear aligner TC-85, Device: 3D printed clear aligner TA-28Results compiled for this aligner from all orders of aligner assignments. |
| Thermoformed clear aligner | Experimental | Device: Thermoformed clear aligner, Device: 3D printed clear aligner TC-85, Device: 3D printed clear aligner TA-28Results compiled for this aligner from all orders of aligner assignments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants are in the permanent dentition
- Participants can understand written English instructions
- Participants have no history of smoking
- Participants will not undergo any active orthodontic treatment.
Key exclusion criteria (2 listed)
- Periodontal disease/gingivitis or craniofacial anomalies.
- Severe tooth crowding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermoformed clear alignerAll participants will receive a thermoformed aligner fabricated from polyethylene terephthalate glycol (PETG) material. This aligner is made from using an intraoral scan to print a 3D model of their maxillary dentition, that is then used for the thermoforming process. This aligner will be worn 20-22 hrs/day for 1 week. | Device | 3D printed clear aligner TA-28, 3D printed clear aligner TC-85, Thermoformed clear aligner |
| 3D printed clear aligner TC-85All participants will receive a 3D printed aligner fabricated from TC-85 resin. This aligner will be made using an Stereolithography (STL) file from their intraoral scan to design the clear aligner and then will be fabricated using the SprintRay Pro 95 S printer. This aligner will be worn 20-22 hrs/day for 1 week. | Device | 3D printed clear aligner TA-28, 3D printed clear aligner TC-85, Thermoformed clear aligner |
| 3D printed clear aligner TA-28All participants will receive a 3D printed aligner fabricated from TA-28 resin. This aligner will be made using an STL file from their intraoral scan to design the clear aligner and then will be fabricated using the SprintRay Pro 95 S printer. This aligner will be worn 20-22 hrs/day for 1 week. | Device | 3D printed clear aligner TA-28, 3D printed clear aligner TC-85, Thermoformed clear aligner |
Primary outcome
Microbial colonization of the tooth surface
Time frame: 1 week Immediately following aligner wear
Assessed using a swab to the tooth surface (three times, once for each aligner)
Microbial composition of inner surface biofilm of aligners
Time frame: 1 week Immediately following aligner wear
Assessed using a swab of the inside of each aligner (three times, once for each aligner)
1 secondary outcome
Patient perception of clear aligners
Time frame: Approximately 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aron Aliaga del Castillo, DDS, MS, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoformed clear aligner, 3D printed clear aligner TC-85 and 3D printed clear aligner TA-28 in people with Orthodontic Aligner and Microbial Colonization, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial colonization of the tooth surface (time frame: 1 week Immediately following aligner wear). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.