Clinical trial NCT06934603: Microplastic Exposure From Clear Aligner Wear (MPE)
Official title: Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microplastic Exposure
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in salivary microplastic size over time.
timeFrame: Pre-treatment through 16-24 weeks post-treatment.
measure: Change in salivary microplastic composition over time.
timeFrame: Pre-treatment through 16-24 weeks post-treatment.
measure: Change in salivary microplastic abundance over time.
timeFrame: Pre-treatment through 16-24 weeks post-treatment.
measure: Change in urinary microplastic size over time.
timeFrame: Pre-treatment through 16-24 weeks post-treatment.
measure: Change in urinary microplastic composition over time.
timeFrame: Pre-treatment through 16-24 weeks post-treatment.
measure: Change in urinary microplastic abundance over time.
timeFrame: Pre-treatment through 16-24 weeks post-treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura A Jacox, DMD, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: