Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT07203456
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing Educational Modalities for Temporomandibular Disorders Curriculum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Educational intervention with virtual patient learning'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-perceived Confidence Level', 'timeFrame': 'Immediately after the educational intervention', 'description': 'Change in confidence level between baseline and after the educational intervention. The self-perceived confidence level will be measured with a 12-item confidence level scale (previously developed and validated by the research group), where answer options range from 0 to 10 on a numerical rating scale (with 0 = "not confident at all" and 10 = "extremely confident"). The 12 items refer to TMD-related skills, including but not limited to providing a treatment plan for patients with TMD, screening of TMD patients, education on the TMD condition, performing diagnostic injections, referring to healthcare providers, among others.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic ability in diagnosing TMD cases', 'timeFrame': 'Immediately after the educational intervention', 'description': 'Change in diagnostic ability in TMD. The diagnostic ability in TMD will be assessed by providing case scenarios featuring signs and symptoms of various TMD conditions. The user will be asked to indicate the TMD diagnosis of the described case. Diagnostic ability will be evaluated based on the accuracy of identifying the correct TMD condition based on the Diagnostic Criteria for TMD (DC/TMD). Answers will be given a score of 1 in case of accurate diagnosis and 0 in case of inaccurate diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Confidence', 'Diagnostic Ability']}, 'descriptionModule': {'briefSummary': 'This study is done to assess the change in confidence level, knowledge, and diagnostic ability in TMD-related aspects through the exposure to a Virtual Patient-Based Learning (VPBL) platform featuring temporomandibular disorder (TMD) cases among 3rd and 4th year predoctoral dental students at a larger predoctoral school.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Third or Fourth year dental students at the College of Dental Medicine at Midwestern University (Illinois)\n\nExclusion Criteria:\n\n* Dental students not enrolled at the third and/or fourth year of the College of Dental Medicine at Midwestern University (Illinois)'}, 'identificationModule': {'nctId': 'NCT07203456', 'briefTitle': 'Testing Educational Modalities for Temporomandibular Disorders Curriculum', 'organization': {'class': 'OTHER', 'fullName': 'Midwestern University'}, 'officialTitle': 'Testing Educational Modalities for Temporomandibular Disorders Curriculum', 'orgStudyIdInfo': {'id': '#IRB-24-0018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clinical exposure to patients with TMD', 'description': 'Participants will be exposed to clinical patients with TMD', 'interventionNames': ['Other: Clinical exposure to patients with TMD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinical exposure to patients with TMD and virtual patient based learning (VPBL)', 'description': 'Participants will be exposed to clinical patients with TMD and to the corresponding virtual patient with the same TMD diagnosis featured on the VPBL', 'interventionNames': ['Other: Clinical exposure to TMD + VPBL']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Patient Based Learning (VPBL)', 'description': 'Participants will be exposed to review virtual patients featured on the VPBL', 'interventionNames': ['Other: Virtual Patient Based Learning (VPBL)']}], 'interventions': [{'name': 'Virtual Patient Based Learning (VPBL)', 'type': 'OTHER', 'description': 'A digital platform featuring 20 virtual patients has been built to increase predoctoral student clinical exposure to patients with TMD signs and symptoms', 'armGroupLabels': ['Virtual Patient Based Learning (VPBL)']}, {'name': 'Clinical exposure to patients with TMD', 'type': 'OTHER', 'description': 'Participants in this arm will be exposed to patients with TMD signs and symptoms, to the history taking, interview, clinical examination, diagnostic process, and treatment plan under the supervision of an orofacial pain specialist', 'armGroupLabels': ['Clinical exposure to patients with TMD']}, {'name': 'Clinical exposure to TMD + VPBL', 'type': 'OTHER', 'description': 'Participants will be exposed to patients with TMD signs and symptoms (including history taking, interview, clinical exam, diagnostic process, and treatment plan) under the supervision of an orofacial pain specialist, and then will be exposed to the corresponding TMD patient on the VPBL, featuring virtual patients with TMD', 'armGroupLabels': ['Clinical exposure to patients with TMD and virtual patient based learning (VPBL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda Sangalli', 'role': 'CONTACT', 'email': 'lsanga@midwestern.edu', 'phone': '630-515-4617'}], 'facility': 'Midwestern University', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}], 'centralContacts': [{'name': 'Linda Sangalli, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'lsanga@midwestern.edu', 'phone': '630-515-4617'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}