Microplastic Exposure From Clear Aligner Wear (MPE)

NCT06934603 | Recruiting

• 1 other identifier: 25-0426
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microplastic Exposure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in salivary microplastic size over time.

  Pre-treatment through 16-24 weeks post-treatment.

• Change in salivary microplastic composition over time.

  Pre-treatment through 16-24 weeks post-treatment.

• Change in urinary microplastic size over time.

  Pre-treatment through 16-24 weeks post-treatment.

• Change in urinary microplastic composition over time.

  Pre-treatment through 16-24 weeks post-treatment.

Study Arms (1)

Clear Aligner Treatment

Orthodontic patients already scheduled to receive clear aligner treatment at UNC Orthodontic clinics.

Other: Clear Aligner Treatment

Interventions

Clear Aligner Treatment OTHER

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

Clear Aligner Treatment

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

This study will collect and retain saliva and urine samples at each of 3 time points.

Study Officials

• Laura A Jacox, DMD, PhD, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura A Jacox, DMD, PhD, MS

CONTACT

919-537-3424; ljacox@live.unc.edu

S.T. Phillips, BSDH

CONTACT

919-537-3422; sherrill_phillips@unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2035
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 and continuing for 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC

Locations

US (1)