NCT06934603 Microplastic Exposure From Clear Aligner Wear (MPE)
| NCT ID | NCT06934603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Microplastic Exposure |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2035-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-08-08 with a primary completion date of 2035-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Eligibility 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
Contact & Investigator
Laura A Jacox, DMD, PhD, MS
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06934603 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 75 Years, studying Microplastic Exposure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06934603 currently recruiting?
Yes, NCT06934603 is actively recruiting participants. Contact the research team at ljacox@live.unc.edu for enrollment information.
Where is the NCT06934603 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06934603 clinical trial?
NCT06934603 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Laura A Jacox, DMD, PhD, MS at University of North Carolina, Chapel Hill. The trial plans to enroll 150 participants.