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NCT Number: NCT06934603

Microplastic Exposure From Clear Aligner Wear (MPE)

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

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Key information

Conditions

Microplastic Exposure

Age range

10 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Laura A Jacox, DMD, PhD, MS

CONTACT

[email protected]

919-537-3424

Laura A Jacox, DMD, PhD, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clear aligner treatment

Other

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

Primary outcomes

  1. Change in salivary microplastic abundance over time.

    Time frame: 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.

  2. Change in urinary microplastic abundance over time.

    Time frame: 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 outcomes

  1. Change in salivary microplastic size over time.

    Time frame: 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.

  2. Change in salivary microplastic composition over time.

    Time frame: 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.

  3. Change in urinary microplastic size over time.

    Time frame: 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.

  4. Change in urinary microplastic composition over time.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura A Jacox, DMD, PhD, MS

CONTACT

[email protected]

919-537-3424

S.T. Phillips, BSDH

CONTACT

[email protected]

919-537-3422

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients

Acronym: MPE

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Apr 18, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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