Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 3:02 PM
Study NCT ID:
NCT06289608
Status:
UNKNOWN
Last Update Posted:
2024-03-04
First Post:
2024-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bruxism and Underlying Psichological Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Level', 'timeFrame': 'baseline', 'description': 'Beck Depression Index. The score range between 0-63, being proprotional to the current depression level'}, {'measure': 'Stress Level', 'timeFrame': 'baseline', 'description': 'Stress Reactitivy Index: Each of the 32 items are coded in a 4-point likert scale format, being 4 the worst category. The summary score is a proportional estimation of the stress level and range from 0-0.5 (minor stress), 0.6-1 (moderate stress) and \\>1 (severe stress)'}, {'measure': 'Anxiety', 'timeFrame': 'baseline', 'description': 'State-Trait Inventory has two estimation of anxiety, as a trait (assessed by 26 items) and as a transitory state (assessed by 20 items). All the items are coded in a 0-3 likert scale. The total score is proportional to the anxiety, being the threshold for determining anxiety above 20 points in male and 25 in females.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bruxism', 'Muscular Disorders, Atrophic', 'Temporomandibular Joint Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory.', 'detailedDescription': 'The Bruxism Self-Reported Index was that reported by Pintado et al.\n\nPintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997;77:313-320.\n\nThe muscular pain was assessed by the last version of the Research Diagnostic Criteria reported by the Schiffman et al in 2014\n\nSchiffman E, et al ; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network\\* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Self-reported bruxists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported Bruxism\n\nExclusion Criteria:\n\n* Refused patients'}, 'identificationModule': {'nctId': 'NCT06289608', 'briefTitle': 'Bruxism and Underlying Psichological Factors', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'Bruxism and Underlying Psichological Factors', 'orgStudyIdInfo': {'id': 'ID_2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Self-reported Bruxism', 'description': 'Those dental patients responding positively to at least 2 of the 6 items of the Pintado et al Self-reported Bruxism Inventory', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No dental intervention was made. Only a clinical examination', 'armGroupLabels': ['Self-reported Bruxism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'JAVIER MONTERO, DDS', 'role': 'CONTACT', 'email': 'javimont@usal.es', 'phone': '619429971'}], 'facility': 'Clinica Odontológica de la Universidad de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'JAVIER MONTERO, PRF', 'role': 'CONTACT', 'email': 'javimont@usal.es', 'phone': '+34 619429971'}, {'name': 'Departamento Cirugía', 'role': 'CONTACT', 'email': 'cirugia@usal.es', 'phone': '+34 923294400', 'phoneExt': '1895'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The aggregated data will be published in a paper of the JCR Dentistry group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'JAVIER MONTERO', 'investigatorAffiliation': 'University of Salamanca'}}}}