Measuring microplastic exposure in patients using clear aligners
Official title: Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
Run by University of North Carolina, Chapel Hill · NCT06934603 · Data updated 2026-11-12
This study is trying to see how clear aligners might affect the levels of microplastics in the saliva and urine of orthodontic patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | August 8, 2025 |
| Main results expected | July 1, 2035 |
| Study ends | July 1, 2035 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06934603 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 10 to 90 years who are scheduled for comprehensive orthodontic treatment with clear aligners and are in stable health.
✕Probably not a fit
Patients receiving fixed orthodontic appliances or those with severe oral health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the levels of microplastic exposure and physiological uptake in orthodontic patients undergoing clear aligner treatment. Participants will provide saliva and urine samples at three different time points: before treatment, 6-12 weeks after starting treatment, and 16-24 weeks after treatment begins. The samples will be analyzed for microplastic content using advanced techniques such as mass spectroscopy, Raman spectroscopy, and scanning electron microscopy. The goal is to understand how clear aligners may influence microplastic exposure over time.
Why it matters
Potential benefit: If successful, this study could provide insights into the health implications of microplastic exposure from dental treatments.
How similar studies have gone: While the investigation of microplastic exposure is a growing field, this specific approach in orthodontic patients is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Laura A Jacox, DMD, PhD, MS — University of North Carolina, Chapel Hill
- Study coordinator: Laura A Jacox, DMD, PhD, MS
- Email: ljacox@live.unc.edu
- Phone: 919-537-3424
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.