NCT06934603

Microplastic Exposure From Clear Aligner Wear (MPE)

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 10 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Microplastic Exposure

Interventions

Type	Name	Description
OTHER	Clear Aligner Treatment	This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.

Timeline

• Start date: 2025-08-08
• Primary completion: 2035-07-01
• Completion: 2035-07-01
• First posted: 2025-04-18
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States