Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
Study NCT ID:
NCT06874868
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2025-03-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary cortisol concentration', 'timeFrame': 'One day', 'description': 'The collection should be performed at the time specified by the physician and at least 30 minutes after the ingestion of solid or liquid foods. A collection tube must be obtained from the laboratory, and the following steps should be followed:\n\nRemove the smaller tube from the collection kit. Open the tube, take out the swab, and place it in the mouth. Gently chew the swab for approximately 1 minute or until swallowing the accumulated saliva becomes unavoidable.\n\nReturn the swab to the smaller tube, ensure it is securely sealed, and then place it inside the larger tube.\n\nImmediately freeze the sample.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular disorders', 'TMD', 'Cortisol'], 'conditions': ['Temporomandibular Joint Disorder']}, 'descriptionModule': {'briefSummary': 't is recognized that cortisol, a hormone produced by the adrenal glands, is a marker that is elevated in patients with psychological disorders, particularly anxiety. On the other hand, Temporomandibular Disorders (TMD) are a condition with a multifactorial etiology, in which emotional disturbances play a crucial role.\n\nTherefore, the aim of this study is to evaluate whether patients with TMD have higher levels of salivary cortisol compared to the general population.\n\nInitially, an assessment will be conducted using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol to determine whether the patient suffer of any kind of Temporomandibular Disorder. Based on the results, individuals will be classified into two groups: the study group, consisting of patients with TMD, and the control group, composed of individuals without the disorder.\n\nThose who agree to participate will be required to sign an informed consent form. Subsequently, a saliva sample will be collected for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals diagnosed with any form of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who attend the dental clinic of the Faculty of Medicine of University of Coimbra\n\nExclusion Criteria:\n\n* Pregnant women, minors and non-autonomous individuals'}, 'identificationModule': {'nctId': 'NCT06874868', 'briefTitle': 'Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Coimbra'}, 'officialTitle': 'Assessment of Salivary Cortisol As a Biomarker in Patients with Temporomandibular Disorder', 'orgStudyIdInfo': {'id': 'FMUCMD2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'Control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000-075', 'city': 'Coimbra', 'state': 'Coimbra District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Bruno Macedo, PhD', 'role': 'CONTACT', 'email': 'brunomacsousa@gmail.com', 'phone': '+351-239 249 151'}], 'facility': 'Faculty of Medicine of University of Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}], 'centralContacts': [{'name': 'Bruno Macedo, PhD', 'role': 'CONTACT', 'email': 'brunomacsousa@gmail.com', 'phone': '+351-239 249 151'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Coimbra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Macedo de Sousa', 'investigatorAffiliation': 'University of Coimbra'}}}}