Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-30 @ 2:44 PM
Study NCT ID:
NCT06934603
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microplastic Exposure From Clear Aligner Wear (MPE)
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPE
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: