Microplastic ExposureDental and oral healthChildren's health
What this study is
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
What's being tested
- Clear Aligner Treatment
Intervention · OTHER
This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.
Study details
- Official title
- Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
- Sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Microplastic Exposure
- Enrolling
- 150 people
- Starts
- 2025-08-08
- Est. completion
- 2035-07-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
- Laura A Jacox, DMD, PhD, MS · Contact919-537-3424ljacox@live.unc.edu
- Laura A Jacox, DMD, PhD, MS · Principal investigator
Recruiting
Study team
Sponsor
University of North Carolina, Chapel Hill
Study ID 25-0426
Principal investigator
Laura A Jacox, DMD, PhD, MS
University of North Carolina, Chapel Hill
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.