Microplastic Exposure From Clear Aligner Wear (MPE) (MPE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Microplastic Exposure
• Intervention / Treatment: Other: 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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Laura A Jacox, DMD, PhD, MS; Phone Number: 919-537-3424; Email: ljacox@live.unc.edu
• Study Contact Backup: Name: S.T. Phillips, BSDH; Phone Number: 919-537-3422; Email: sherrill_phillips@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Laura A Jacox, DMD, PhD, MS; Phone Number: 919-537-3424; Email: ljacox@live.unc.edu
      • Principal Investigator: Laura A Jacox, DMD, PhD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients identified from UNC orthodontic clinics who are scheduled (prior to study engagement) to receive clear aligner treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clear Aligner Treatment; Orthodontic patients already scheduled to receive clear aligner treatment at UNC Orthodontic clinics.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in salivary microplastic abundance over time.	Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.	Pre-treatment through 16-24 weeks post-treatment.
Change in urinary microplastic abundance over time.	Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.	Pre-treatment through 16-24 weeks post-treatment.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Laura A Jacox, DMD, PhD, MS, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2035

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25-0426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: Beginning 9 and continuing for 36 months following publication.
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No