NCT06934603 · University of North Carolina, Chapel Hill
Microplastic Exposure From Clear Aligner Wear (MPE)
(MPE)
What this study is about
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
View original scientific description
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Interventions
OTHER
Clear Aligner Treatment
This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Chapel Hill, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2025 · Source of record for eligibility and locations