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Recruiting NCT06934603

Microplastic Exposure From Clear Aligner Wear (MPE)

— Observational Microplastic Exposure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clear Aligner Treatment.
Who it may be relevant to
Registry conditions: Microplastic Exposure. Basic parameters: 10 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in salivary microplastic abundance over time. [Time frame: Pre-treatment through 16-24 weeks post-treatment.]
  • Change in urinary microplastic abundance over time. [Time frame: Pre-treatment through 16-24 weeks post-treatment.]
Secondary outcome measures (4)
  • Change in salivary microplastic size over time. [Time frame: Pre-treatment through 16-24 weeks post-treatment.]
  • Change in salivary microplastic composition over time. [Time frame: Pre-treatment through 16-24 weeks post-treatment.]
  • Change in urinary microplastic size over time. [Time frame: Pre-treatment through 16-24 weeks post-treatment.]
  • Change in urinary microplastic composition over time. [Time frame: Pre-treatment through 16-24 weeks post-treatment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT06934603 · 25-0426

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗