Status:
RECRUITING
Microplastic Exposure From Clear Aligner Wear (MPE)
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Microplastic Exposure
Eligibility:
All Genders
10-75 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2035
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06934603
Start Date
August 8 2025
End Date
July 1 2035
Last Update
September 19 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599