Microplastic Exposure From Clear Aligner Wear (MPE)

University of North Carolina (UNC)

Status

Enrolling

Conditions

Microplastic Exposure

Treatments

Other: Clear Aligner Treatment

Study type

Observational

Funder types

Other

Identifiers

NCT06934603

25-0426

Details and patient eligibility

About

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

Full 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. Consented and enrolled participants will provide unstimulated saliva and urine samples at three timepoints before regularly scheduled orthodontic appointments: Pre-treatment (Visit 1), 6-12 weeks post-treatment (Visit 2), and 16-24 weeks post-treatment (Visit 3). The saliva and urine samples will be filtered and then analyzed for microplastic content using mass spectroscopy, Raman spectroscopy and scanning electron microscopy approaches.

Enrollment

150 estimated patients

Sex

All

Ages

10 to 75 years old

Volunteers

No Healthy Volunteers

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