Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04582851
Status:
UNKNOWN
Last Update Posted:
2021-08-04
First Post:
2020-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Temporomandibular Joint Disorders Among Egyptian University Postgraduate Students
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': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2020-10-04', 'studyFirstSubmitQcDate': '2020-10-04', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of TMDs in Egyptian university students', 'timeFrame': '3 months', 'description': 'by fonseca questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Joint Disorders']}, 'descriptionModule': {'briefSummary': 'The study will take place in Egypt. Postgraduate students from different faculties of the Egyptian Universities will participate. The study will begin in Decemberr 2020.', 'detailedDescription': 'Matching criteria and allocation ratio The planned study a single arm cross sectional study, in which the prevalence of students of TMD will be reported. The association between TMD and other variables will be also studied. Gender, Age, Psychological stress, non-nutritional oral habits as nail biting, lip biting, object biting and grinding of teeth (bruxism \\& clenching), Para-functional habits, such as intensive gum chewing, leaning of the chin on the hand and mouth breathing , previous dental treatment and previous jaw trauma will be all studied.\n\nData sources and management Data sources, the answered questionnaires and subsequent spread sheets will only be shared by the team members.\n\nddressing potential sources of bias Selection bias: Sampling will be convenient sampling, Questionnaires will be handed to the students, otherwise an email will be sent to all the students through their university email addresses if COVID-19 situation prevails.\n\nStatistical methods Statistical methods\n\nAll confounders, effect modifiers and exposures will be controlled for by crude and adjusted regression analyses, where the primary analysis will be the adjusted one. Failure to do so as a result of violating principles of a regression model will call for a subgroup analysis, where a student t test will be used for the comparison between the subgroups.\n\nIt is also planned to study the interactions between the variables via ANOVA test if the data show normal distribution.\n\nParticipants with missing data will be excluded.\n\n\\- Cross-sectional study-Since the planned sampling method is cluster sampling, where the design effect factor becomes greater than 1.\n\nSensitivity of the results to adjusted and crude analysis will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postgraduate students in Egyptian universities', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Postgraduate students in Egyptian universities\n2. Age ranges from 18-45 years\n3. Males and females\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04582851', 'briefTitle': 'Prevalence of Temporomandibular Joint Disorders Among Egyptian University Postgraduate Students', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Temporomandibular Joint Disorders Among Egyptian University Postgraduate Students', 'orgStudyIdInfo': {'id': '9102020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postgraduate students', 'description': 'prevalence of TMD among postgraduate students.', 'interventionNames': ['Other: some risk factors correlated with TMD']}], 'interventions': [{'name': 'some risk factors correlated with TMD', 'type': 'OTHER', 'description': 'exposure factors causing TMD', 'armGroupLabels': ['Postgraduate students']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11518', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmad Diab', 'role': 'CONTACT'}, {'name': 'Mohamed Khashab, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmad Diab', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maram Taema, masters', 'role': 'CONTACT', 'email': 'maram.taema@dentistry.cu.edu.eg', 'phone': '01005487077'}, {'name': 'Iman Radi, masters', 'role': 'CONTACT', 'email': 'iman.abdelwahab@dentistry.cu.edu.eg', 'phone': '01001539613'}], 'overallOfficials': [{'name': 'Ahmed Diab, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Essam Aziz, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Iman Radi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Maram Taema, Masters', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'mohamed khashab, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Maram Ahmed Taema', 'investigatorAffiliation': 'Cairo University'}}}}