Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05751902
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translation and Validation of the Arabic Version of the OHIP Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 254}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-27', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability and validity', 'timeFrame': '3 months', 'description': 'Reliability of Translated Arabic version of OHIP questionnaire using internal consistency'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Health', 'Surveys and Questionnaires']}, 'descriptionModule': {'briefSummary': 'OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. As people living in middle east are mainly influenced by the Arabic culture, which differs significantly from the Western culture where the OHIP questionnaire was first developed.\n\n254 participants having removable prosthesis will be asked to complete translated Arabic version of OHIP questionnaire for validation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any participant fluent in Arabic language and having a removable prosthesis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having removable partial denture in the last year\n* Native Arabic patients\n\nExclusion Criteria:\n\n* Patients non familiar with Arabic language\n* patients with mental or perception problems'}, 'identificationModule': {'nctId': 'NCT05751902', 'briefTitle': 'Translation and Validation of the Arabic Version of the OHIP Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Translation and Validation of the Arabic Version of the Oral Health Impact Profile Questionnaire', 'orgStudyIdInfo': {'id': 'FUE.REC (1)/1-2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Arabic version of OHIP questionnaire', 'type': 'OTHER', 'description': 'Translated Arabic version of Oral Health Impact Profile questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '111111', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Medhat Abdelaziz, MSc.', 'role': 'CONTACT', 'email': 'dr.medhatsameh@gmail.com', 'phone': '01094023661'}], 'facility': 'Future University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Medhat Abdelaziz, M.S.C', 'role': 'CONTACT', 'email': 'medhat.abdelaziz@fue.edu.eg', 'phone': '00201094023661'}], 'facility': 'Future University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Prosthodontics', 'investigatorFullName': 'Medhat Sameh Abdelaziz', 'investigatorAffiliation': 'Future University in Egypt'}}}}