Microplastic Exposure From Clear Aligner Wear (MPE)
United States150 participantsStarted 2025-08-08
Plain-language summary
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Who can participate
Age range10 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in salivary microplastic abundance over time.
Timeframe: Pre-treatment through 16-24 weeks post-treatment.
2
Change in urinary microplastic abundance over time.
Timeframe: Pre-treatment through 16-24 weeks post-treatment.