Microplastic ExposureMPENCT06934603
Microplastic Exposure From Clear Aligner Wear (MPE)
An observational study of Microplastic Exposure, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Microplastic Exposure
- What is being tested?
- Clear Aligner Treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 1 Jul 2035
- Phase
- Observational
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes patients identified from UNC orthodontic clinics who are scheduled (prior to study engagement) to receive clear aligner treatment.
Who may be able to join
- Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 75 years
- Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
- Stable physical health (ASA I or II), as determined by study coordinator or PI
- Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
- Patient and parental consent (and assent for minors) for participation in the study
Who cannot join
- Receiving orthodontic treatment with fixed appliances
- Receiving hybrid treatment with fixed appliances and aligners
- Receiving Phase I orthodontic treatment with fixed appliances
- Established history of severe xerostomia (dry mouth), severe periodontal disease with actively bleeding gums, significant oral abrasions/ulcers or growths, current alcohol abuse, and/or recreational drug abuse
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation
- Drinking, eating, or brushing teeth within 1 hour of study visit
- Removing aligners within 1 hour of study visit
- Developmental or cognitive disability such that the patient cannot self-consent, comprehend, and follow the requirements of the study based on research site personnel's assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Laura A Jacox, DMD, PhD, MS, 919-537-3424, ljacox@live.unc.edu
Laura A Jacox, DMD, PhD, MS
About this study
Official title: Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Read the detailed description
This study is investigating whether orthodontic patients already scheduled to receive clear aligner treatment have changes in their microplastic exposure and physiologic uptake pre- and post-treatment. Consented and enrolled participants will provide unstimulated saliva and urine samples at three timepoints before regularly scheduled orthodontic appointments: Pre-treatment (Visit 1), 6-12 weeks post-treatment (Visit 2), and 16-24 weeks post-treatment (Visit 3). The saliva and urine samples will be filtered and then analyzed for microplastic content using mass spectroscopy, Raman spectroscopy and scanning electron microscopy approaches.
- Conditions
- Microplastic Exposure
- Being tested
- Clear Aligner Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Aligner TreatmentOther
This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligner Treatment | Orthodontic patients already scheduled to receive clear aligner treatment at UNC Orthodontic clinics. Receives: Other: Clear Aligner Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary microplastic abundance over time.
Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Measured: Pre-treatment through 16-24 weeks post-treatment.
Change in urinary microplastic abundance over time.
Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Measured: Pre-treatment through 16-24 weeks post-treatment.
Secondary outcomes (4)
Change in salivary microplastic size over time.
Differences in microplastic size in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Measured: Pre-treatment through 16-24 weeks post-treatment.
Change in salivary microplastic composition over time.
Differences in microplastic identities in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Measured: Pre-treatment through 16-24 weeks post-treatment.
Change in urinary microplastic size over time.
Differences in microplastic size in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Measured: Pre-treatment through 16-24 weeks post-treatment.
Change in urinary microplastic composition over time.
Differences in microplastic identities in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Measured: Pre-treatment through 16-24 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start8 Aug 2025
- Primary completion1 Jul 2035 (estimated)
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microplastic ExposureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura A Jacox, DMD, PhD, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934603
- Sponsor's protocol ID
- 25-0426
- Acronym
- MPE
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
- ClinicalTrials.gov ID
- NCT06934603
- Acronym / sponsor ID
- MPE / 25-0426
- Conditions
- Microplastic Exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 1 Jul 2035 (estimated)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 18 Apr 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.
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Detailed description
This study is investigating whether orthodontic patients already scheduled to receive clear aligner treatment have changes in their microplastic exposure and physiologic uptake pre- and post-treatment. Consented and enrolled participants will provide unstimulated saliva and urine samples at three timepoints before regularly scheduled orthodontic appointments: Pre-treatment (Visit 1), 6-12 weeks post-treatment (Visit 2), and 16-24 weeks post-treatment (Visit 3). The saliva and urine samples will be filtered and then analyzed for microplastic content using mass spectroscopy, Raman spectroscopy and scanning electron microscopy approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clear Aligner Treatment | – | Other: Clear Aligner TreatmentOrthodontic patients already scheduled to receive clear aligner treatment at UNC Orthodontic clinics. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes patients identified from UNC orthodontic clinics who are scheduled (prior to study engagement) to receive clear aligner treatment.
Key inclusion criteria (5 listed)
- Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 75 years
- Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
- Stable physical health (ASA I or II), as determined by study coordinator or PI
- Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
- Patient and parental consent (and assent for minors) for participation in the study
Key exclusion criteria (8 listed)
- Receiving orthodontic treatment with fixed appliances
- Receiving hybrid treatment with fixed appliances and aligners
- Receiving Phase I orthodontic treatment with fixed appliances
- Established history of severe xerostomia (dry mouth), severe periodontal disease with actively bleeding gums, significant oral abrasions/ulcers or growths, current alcohol abuse, and/or recreational drug abuse
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation
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 |
|---|---|---|
| Clear Aligner TreatmentThis study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited. | Other | Clear Aligner Treatment |
Primary outcome
Change in salivary microplastic abundance over time.
Time frame: Pre-treatment through 16-24 weeks post-treatment.
Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in urinary microplastic abundance over time.
Time frame: Pre-treatment through 16-24 weeks post-treatment.
Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
4 secondary outcomes
Change in salivary microplastic size over time.
Time frame: Pre-treatment through 16-24 weeks post-treatment.
Change in salivary microplastic composition over time.
Time frame: Pre-treatment through 16-24 weeks post-treatment.
Change in urinary microplastic size over time.
Time frame: Pre-treatment through 16-24 weeks post-treatment.
Change in urinary microplastic composition over time.
Time frame: Pre-treatment through 16-24 weeks post-treatment.
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 19 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Laura A Jacox, DMD, PhD, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microplastic Exposure, run by University of North Carolina, Chapel Hill 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Sep 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?
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?
Contact Laura A Jacox, DMD, PhD, MS (919-537-3424, ljacox@live.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary microplastic abundance over time. (time frame: Pre-treatment through 16-24 weeks post-treatment.). 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 19 Sep 2025.