Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT06623851
Status:
RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in child discomfort', 'timeFrame': 'intraoperative', 'description': "Children's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis."}, {'measure': 'Change in dental anxiety', 'timeFrame': 'intraoperative', 'description': "Dental anxiety will be recorded using the Facial Image Scale (FIS) Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling."}], 'secondaryOutcomes': [{'measure': 'Gag reflex', 'timeFrame': 'post procedure', 'description': "After taking the impressions, child's gag reflex will be assessed. Gag sensitivity is ranked on a scale from 1 (least severe) to 5 (most severe) using the Gagging Severity Index (GSI)"}, {'measure': 'Assessment of level of child cooperation', 'timeFrame': 'intraoperative', 'description': "Venham's Behavior rating scale classifies the child's behavior into 6 categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a score of 5 refers to complete absence of compliance and cooperation and the requirement of physical restraint"}, {'measure': 'procedure time', 'timeFrame': 'intraoperative', 'description': 'Time taken from scanning and taking impression for the lower and upper jaws to the final bite registeration. Time will be recorded in minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental impression', 'Digital impression'], 'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': "Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.\n\nObjectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.\n\nMaterials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.\n* No previous dental experience.\n* Patient's parents signed an informed consent before participating in the trial.\n\nExclusion Criteria:\n\n* Any physical or mental disability, or psychological problems.\n* Children with temporomandibular joint or periodontal discomfort"}, 'identificationModule': {'nctId': 'NCT06623851', 'briefTitle': 'Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '0863-2/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital dental Impression', 'interventionNames': ['Other: Intraoral scanner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional dental impression', 'interventionNames': ['Other: Alginate impression']}], 'interventions': [{'name': 'Intraoral scanner', 'type': 'OTHER', 'description': '* The digital impressions will be made with the intraoral scanner following the procedure reported by the manufacturer.\n* The intraoral scanning process is divided into the lower jaw scan, upper jaw scan, and bite scan stages', 'armGroupLabels': ['Digital dental Impression']}, {'name': 'Alginate impression', 'type': 'OTHER', 'description': "Conventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate", 'armGroupLabels': ['Conventional dental impression']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Arwa Ghoneim, BDS', 'role': 'CONTACT', 'email': 'arwaghoneim1992@gmail.com', 'phone': '01204666655'}, {'name': 'Arwa Gohneim, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Arwa Ghoneim, BDS', 'role': 'CONTACT', 'email': 'arwaghoneim1992@gmail.com', 'phone': '01204666655'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health and biostatistical consultanat', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}