Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 9:50 AM
Study NCT ID:
NCT04815759
Status:
UNKNOWN
Last Update Posted:
2021-03-25
First Post:
2021-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Anxiety Among Children Pre and Post COVID 19 Pandemic
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': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2021-03-20', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental anxiety level', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Assessment will performed by using Facial image scale (FIS)It consists of 5 faces ranging from very happy to very unhappy.\n\nAt the beginning, the 5 faces have been explained to all children and they were asked to point to the face which best describes how he/she felt at the moment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with an age range 4-6 years attending the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parental consent\n* no previous dental experience\n* medically free children\n\nExclusion Criteria:\n\n* children with negative behavior according to Frankl Rating Scale\n* children require general anesthesia'}, 'identificationModule': {'nctId': 'NCT04815759', 'briefTitle': 'Dental Anxiety Among Children Pre and Post COVID 19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Dental Anxiety Among Egyptian Children Pre and Post COVID 19', 'orgStudyIdInfo': {'id': 'Dental anxiety'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre pandemic', 'interventionNames': ['Other: routine dental restorative procedures']}, {'label': 'Post pandemic', 'interventionNames': ['Other: routine dental restorative procedures']}], 'interventions': [{'name': 'routine dental restorative procedures', 'type': 'OTHER', 'description': 'pulp and restorative therapy', 'armGroupLabels': ['Post pandemic', 'Pre pandemic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dalia M Talaat', 'role': 'CONTACT', 'phone': '01221037275'}], 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Dalia M Talaat, phd', 'role': 'CONTACT', 'email': 'dalia.talaat@dent.alex.edu.eg', 'phone': '01221037275'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}