Microplastic Exposure
Conditions
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.
Interventions
This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.
Sponsors
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary microplastic abundance over time. | Pre-treatment through 16-24 weeks post-treatment. | Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment. |
| Change in urinary microplastic abundance over time. | Pre-treatment through 16-24 weeks post-treatment. | Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary microplastic size over time. | Pre-treatment through 16-24 weeks post-treatment. | Differences in microplastic size in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment. |
| Change in salivary microplastic composition over time. | Pre-treatment through 16-24 weeks post-treatment. | Differences in microplastic identities in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment. |
| Change in urinary microplastic size over time. | Pre-treatment through 16-24 weeks post-treatment. | Differences in microplastic size in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment. |
| Change in urinary microplastic composition over time. | Pre-treatment through 16-24 weeks post-treatment. | Differences in microplastic identities in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment. |
Countries
United States
Contacts
Primary ContactLaura A Jacox, DMD, PhD, MS
Backup ContactS.T. Phillips, BSDH
Outcome results
None listed