Adaptation of Different Types of Clear AlignersNCT07639515
Randomized In-Vivo Comparison of 3D-Printed and Thermoformed Clear Aligners: A Multi-Subject, Time-Dependent Analysis of Adaptation and Trueness
A study testing Device: Invisalign Passive Clear Aligner, Spark Passive aligners and Zendura passive aligner in people with Adaptation of Different Types of Clear Aligners, run by University of Florida.
Trial summary
This prospective clinical study aims to evaluate and compare the in vivo adaptation and trueness of clear aligners fabricated using thermoforming and direct three-dimensional (3D) printing technologies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adaptation of Different Types of Clear Aligners
- What is being tested?
- Device: Invisalign Passive Clear Aligner, Spark Passive aligners and Zendura passive aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 6 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy adult volunteers aged 18 years or older.
- Good general and oral health.
- Dentition adequate to support passive upper clear aligner wear, as determined by the investigator.
- Willing and able to attend all study visits over the 4-6 month study period.
- Willing and able to comply with aligner wear and all study procedures.
- Able to provide written informed consent and HIPAA authorization.
Who cannot join
- Active dental or periodontal disease, or any oral condition that could interfere with study procedures.
- Need for active orthodontic treatment or other dental procedures during the study period.
- Poor oral hygiene or failure to follow study instructions at the screening visit.
- Medical or systemic conditions, or use of medications, that could compromise participation or study outcomes.
- Concurrent participation in another interventional research study.
- Pregnancy or planned pregnancy during the study period (if applicable).
About this study
Official title: 3D-Printed and Thermoformed Clear Aligners: Analysis of Adaptation and Trueness.
This prospective clinical study aims to evaluate and compare the in vivo adaptation and trueness of clear aligners fabricated using thermoforming and direct three-dimensional (3D) printing technologies.
- Being tested
- Device: Invisalign Passive Clear Aligner, Spark Passive aligners, Zendura passive aligner, Graphy passive aligner, Luxcreo passive aligner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Invisalign Passive Clear AlignerDevice
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
Spark Passive alignersDevice
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
Zendura passive alignerDevice
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
Graphy passive alignerDevice
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
Luxcreo passive alignerDevice
Participants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time.
| Study group | Role | What they receive |
|---|---|---|
| Attachment group | Experimental | Not described Receives: Device: Device: Invisalign Passive Clear Aligner; Device: Spark Passive aligners; Device: Zendura passive aligner; Device: Graphy passive aligner; Device: Luxcreo passive aligner |
| No attachment group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments.
Mean 3D distance (millimeters) between the inner surface of the passive clear aligner and the corresponding tooth surface, computed from superimposed digital intraoral scans at baseline, 24 hours, 7 days, and 14 days of wear for each aligner system, comparing attachment and non-attachment groups
Measured: Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completion21 Feb 2028 (estimated)
- Study completion6 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adaptation of Different Types of Clear AlignersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639515
- Sponsor's protocol ID
- IRB202600622
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Printed and Thermoformed Clear Aligners: Analysis of Adaptation and Trueness.
- ClinicalTrials.gov ID
- NCT07639515
- Acronym / sponsor ID
- IRB202600622
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 21 Feb 2028 (estimated)
- Study completion
- 6 Apr 2028 (estimated)
- First posted
- 10 Jun 2026 (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 prospective clinical study aims to evaluate and compare the in vivo adaptation and trueness of clear aligners fabricated using thermoforming and direct three-dimensional (3D) printing technologies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attachment group | Experimental | Device: Device: Invisalign Passive Clear Aligner, Device: Spark Passive aligners, Device: Zendura passive aligner, Device: Graphy passive aligner, Device: Luxcreo passive aligner |
| No attachment group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult volunteers aged 18 years or older.
- Good general and oral health.
- Dentition adequate to support passive upper clear aligner wear, as determined by the investigator.
- Willing and able to attend all study visits over the 4-6 month study period.
- Willing and able to comply with aligner wear and all study procedures.
Key exclusion criteria (6 listed)
- Active dental or periodontal disease, or any oral condition that could interfere with study procedures.
- Need for active orthodontic treatment or other dental procedures during the study period.
- Poor oral hygiene or failure to follow study instructions at the screening visit.
- Medical or systemic conditions, or use of medications, that could compromise participation or study outcomes.
- Concurrent participation in another interventional research study.
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 |
|---|---|---|
| Device: Invisalign Passive Clear AlignerParticipants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time. | Device | Attachment group |
| Spark Passive alignersParticipants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time. | Device | Attachment group |
| Zendura passive alignerParticipants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time. | Device | Attachment group |
| Graphy passive alignerParticipants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time. | Device | Attachment group |
| Luxcreo passive alignerParticipants will wear a passive fabricated from unchanged digital models and not intended to move teeth or provide orthodontic treatment. The aligner will be worn full-time for 14 days, followed by a 48-hour washout period before the next system, with digital intraoral scans obtained at baseline, 24 hours, 7 days, and 14 days to assess aligner adaptation and trueness over time. | Device | Attachment group |
Primary outcome
Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments.
Time frame: Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days).
Mean 3D distance (millimeters) between the inner surface of the passive clear aligner and the corresponding tooth surface, computed from superimposed digital intraoral scans at baseline, 24 hours, 7 days, and 14 days of wear for each aligner system, comparing attachment and non-attachment groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Invisalign Passive Clear Aligner, Spark Passive aligners and Zendura passive aligner in people with Adaptation of Different Types of Clear Aligners, run by University of Florida.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Aligner-tooth adaptation (3D gap distance) for each clear aligner system, with and without attachments. (time frame: Up to 14 days of wear for each aligner system (assessed at baseline, 24 hours, 7 days, and 14 days).). 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 12 Jun 2026.