Microplastic Exposure From Clear Aligner Wear (MPE)

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Apr 11, 2025

Keywords

ClinConnect Summary

The Microplastic Exposure From Clear Aligner Wear (MPE) trial is a study looking at how wearing clear aligners for orthodontic treatment may expose patients to microplastics, tiny particles that can be found in various products. This research aims to understand whether these microplastics are absorbed by the body and how they might affect health. The study is currently recruiting participants aged between 10 and 90 years who are receiving specific orthodontic treatments with clear aligners and are in good health.

To participate, individuals must be able to follow the study guidelines and provide consent, which can also include parental consent for minors. Participants will need to attend scheduled visits, where they may be asked questions or undergo simple assessments related to their treatment. It's important to note that individuals receiving different types of orthodontic treatments, like fixed braces, or those with certain health conditions, cannot join the study. This trial not only seeks to gather valuable information but also aims to ensure the safety and well-being of all participants throughout the process.

Gender

ALL

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