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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'This study will collect and retain saliva and urine samples at each of 3 time points.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2035-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in salivary microplastic abundance over time.', 'timeFrame': 'Pre-treatment through 16-24 weeks post-treatment.', 'description': 'Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.'}, {'measure': 'Change in urinary microplastic abundance over time.', 'timeFrame': 'Pre-treatment through 16-24 weeks post-treatment.', 'description': 'Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in salivary microplastic size over time.', 'timeFrame': 'Pre-treatment through 16-24 weeks post-treatment.', 'description': 'Differences in microplastic size in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.'}, {'measure': 'Change in salivary microplastic composition over time.', 'timeFrame': 'Pre-treatment through 16-24 weeks post-treatment.', 'description': 'Differences in microplastic identities in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.'}, {'measure': 'Change in urinary microplastic size over time.', 'timeFrame': 'Pre-treatment through 16-24 weeks post-treatment.', 'description': 'Differences in microplastic size in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.'}, {'measure': 'Change in urinary microplastic composition over time.', 'timeFrame': 'Pre-treatment through 16-24 weeks post-treatment.', 'description': 'Differences in microplastic identities in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microplastic Exposure']}, 'descriptionModule': {'briefSummary': 'An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients identified from UNC orthodontic clinics who are scheduled (prior to study engagement) to receive clear aligner treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 75 years\n* Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy\n* Stable physical health (ASA I or II), as determined by study coordinator or PI\n* Able to comprehend and follow requirements of study (including availability on scheduled visit dates)\n* Patient and parental consent (and assent for minors) for participation in the study\n\nExclusion Criteria:\n\n* Receiving orthodontic treatment with fixed appliances\n* Receiving hybrid treatment with fixed appliances and aligners\n* Receiving Phase I orthodontic treatment with fixed appliances\n* 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\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation\n* Drinking, eating, or brushing teeth within 1 hour of study visit\n* Removing aligners within 1 hour of study visit\n* 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"}, 'identificationModule': {'nctId': 'NCT06934603', 'acronym': 'MPE', 'briefTitle': 'Microplastic Exposure From Clear Aligner Wear (MPE)', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients', 'orgStudyIdInfo': {'id': '25-0426'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clear Aligner Treatment', 'description': 'Orthodontic patients already scheduled to receive clear aligner treatment at UNC Orthodontic clinics.', 'interventionNames': ['Other: Clear Aligner Treatment']}], 'interventions': [{'name': 'Clear Aligner Treatment', 'type': 'OTHER', 'description': 'This study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.', 'armGroupLabels': ['Clear Aligner Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura A Jacox, DMD, PhD, MS', 'role': 'CONTACT', 'email': 'ljacox@live.unc.edu', 'phone': '919-537-3424'}, {'name': 'Laura A Jacox, DMD, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Laura A Jacox, DMD, PhD, MS', 'role': 'CONTACT', 'email': 'ljacox@live.unc.edu', 'phone': '919-537-3424'}, {'name': 'S.T. Phillips, BSDH', 'role': 'CONTACT', 'email': 'sherrill_phillips@unc.edu', 'phone': '919-537-3422'}], 'overallOfficials': [{'name': 'Laura A Jacox, DMD, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 9 and continuing for 36 months following publication.', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}