Recruiting

Microplastic Exposure

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06934603

Conditions

Microplastic Exposure

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Interventions

Clear Aligner Treatment

Study Details

Brief summary:

An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.

Conditions

Microplastic Exposure

Study ID

NCT06934603

Start date

Aug 8, 2025

Status verified date

Sep, 2025

Completion date

Jul 1, 2035

Anticipated

Primary completion date

Jul 1, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Clear Aligner Treatment

Orthodontic patients already scheduled to receive clear aligner treatment at UNC Orthodontic clinics.

Interventions

Clear Aligner Treatment

This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.

Primary outcome measure

  • Change in salivary microplastic abundance over time. [ Time Frame: Pre-treatment through 16-24 weeks post-treatment. ]
  • Change in urinary microplastic abundance over time. [ Time Frame: Pre-treatment through 16-24 weeks post-treatment. ]

Central Contacts and Locations

Central contacts

Laura A Jacox, DMD, PhD, MS

919-537-3424ljacox@live.unc.edu

S.T. Phillips, BSDH

919-537-3422sherrill_phillips@unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Laura A Jacox, DMD, PhD, MS

919-537-3424ljacox@live.unc.edu

Principal Investigator:

Laura A Jacox, DMD, PhD, MS

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-09-19.