Microplastic Exposure From Clear Aligner Wear (MPE)

Recruiting

• Conditions: Microplastic Exposure

• Registration Number: NCT06934603
• Lead Sponsor: University of North Carolina, Chapel Hill

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. 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2035-05
• Study Completion: 2035-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 90 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in salivary microplastic size over time.	Pre-treatment through 16-24 weeks post-treatment.	Differences in microplastic size in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in salivary microplastic composition over time.	Pre-treatment through 16-24 weeks post-treatment.	Differences in microplastic identities in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in salivary microplastic abundance over time.	Pre-treatment through 16-24 weeks post-treatment.	Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in urinary microplastic size over time.	Pre-treatment through 16-24 weeks post-treatment.	Differences in microplastic size in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in urinary microplastic composition over time.	Pre-treatment through 16-24 weeks post-treatment.	Differences in microplastic identities in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Change in urinary microplastic abundance over time.	Pre-treatment through 16-24 weeks post-treatment.	Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States