Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-01 @ 1:41 AM
Study NCT ID:
NCT04592133
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2020-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Temporomandibular Joint Pathologies in Scoliosis Patients With Ultrasonography and Clinical Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-09', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint Pain Scale', 'timeFrame': '7 month', 'description': 'Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonography'], 'conditions': ['Scoliosis Patients']}, 'referencesModule': {'references': [{'pmid': '21801357', 'type': 'BACKGROUND', 'citation': 'Saccucci M, Tettamanti L, Mummolo S, Polimeni A, Festa F, Tecco S. Scoliosis and dental occlusion: a review of the literature. Scoliosis. 2011 Jul 29;6:15. doi: 10.1186/1748-7161-6-15.'}, {'pmid': '17218718', 'type': 'BACKGROUND', 'citation': 'Tecco S, Festa F. Cervical spine curvature and craniofacial morphology in an adult Caucasian group: a multiple regression analysis. Eur J Orthod. 2007 Apr;29(2):204-9. doi: 10.1093/ejo/cjl061. Epub 2007 Jan 11.'}, {'type': 'BACKGROUND', 'citation': 'Ito, G., & Yamazaki, K. (1995). Relation between posture and the maxillofacial cranium. Jpn Dent Assoc, 48, 15-26.'}], 'seeAlsoLinks': [{'url': 'http://www.tmj.org/', 'label': 'Joint, J. (2010). TMJ. Association. TMJ diseases and disorders: Basics-overview.'}]}, 'descriptionModule': {'briefSummary': 'From the anatomical and functional point of view, stomatognathic system and spine have close connections. Together with the complex neuromuscular relationships, this creates an important area of cooperation between dentists and orthopedics (1). The cause of scoliosis has not been precisely explained, and various causes have been suggested in the literature, such as deviation from the standard growth pattern, neuromuscular tissue changes, asymmetric growth of the trunk, changes in the sagittal configuration of the spine, and environmental factors. In addition, scoliosis may develop secondary to each of hereditary musculoskeletal disorders such as osteogenesis imperfecta, Marfan syndrome, Stickler syndrome, Ehlers-Danlos syndrome and muscular dystrophies.\n\nFonder et al. conducted case studies showing the relationship between dental occlusion and scoliosis (2). There are studies suggesting that temporomandibular joint (TMJ) diseases are observed more frequently with the effect of the head-neck muscle balance affected by scoliosis and the irregularities in the occlusion. At the same time, some studies have shown that patients with mandible changes (deviation, deflection, asymmetry…), which is one of the TMJ components, often have abnormal morphology in the cervical vertebrae (3). Ito G et al. They reported that body posture is closely related to the function of the head support system. The cervical spine and muscles play an important role in stabilizing the head posture and in the complex and various movements of the head (4).\n\nThere is no study in the literature comparing the severity of scoliosis and TMJ joint dysfunction radiologically and clinically.\n\nIn this study, TMJ of scoliosis patients was evaluated by ultrasonography and clinical examination; It was aimed to correlate the severity of scoliosis with joint dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patient population admitted to our clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 12-18\n* Being diagnosed with Adolescent Idiopathic Scoliosis\n\nExclusion Criteria:\n\n* Being diagnosed with neuromuscular, juvenile or congenital scoliosis\n* Having received surgical treatment for scoliosis\n* Rheumatological disease\n* Having received treatment for TMJ dysfunction'}, 'identificationModule': {'nctId': 'NCT04592133', 'briefTitle': 'Prospective Evaluation of Temporomandibular Joint Pathologies in Scoliosis Patients With Ultrasonography and Clinical Examination', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Prospective Evaluation of Temporomandibular Joint Pathologies in Scoliosis Patients With Ultrasonography and Clinical Examination', 'orgStudyIdInfo': {'id': '2020/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Scoliosis Patients', 'interventionNames': ['Diagnostic Test: Ultrasonography']}, {'label': 'Control Group', 'interventionNames': ['Diagnostic Test: Ultrasonography']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasonography Examination', 'armGroupLabels': ['Control Group', 'Scoliosis Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Dentistry Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Merve Yelken Kendirci', 'investigatorAffiliation': 'Istanbul University'}}}}