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RecruitingNCT06934603

Microplastic Exposure From Clear Aligner Wear (MPE)

Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients

Sponsor

University of North Carolina, Chapel Hill

Enrollment

150 participants

Start Date

Aug 8, 2025

Study Type

OBSERVATIONAL

Conditions

Microplastic Exposure

Summary

An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.

Eligibility

Min Age: 10 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

OTHERClear Aligner Treatment

This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.

Locations(1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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NCT06934603