Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05608720
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preparation Protocol for the First Pediatric Dental Visit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)", 'timeFrame': 'immediately after the intervention', 'description': 'FBRS: values from 1 (Definitely negative) to 4 (definitely positive)'}], 'secondaryOutcomes': [{'measure': 'self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)', 'timeFrame': 'immediately after the intervention', 'description': 'WBFPRS: from 0 (no hurt) to 10 (hurts worst)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['behavior management', 'first dental visit'], 'conditions': ['Behavior, Child', 'Dentist-Patient Relations']}, 'descriptionModule': {'briefSummary': "To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit", 'detailedDescription': "The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child requiring a first dental visit\n\nExclusion Criteria:\n\n* previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address'}, 'identificationModule': {'nctId': 'NCT05608720', 'acronym': 'PREP', 'briefTitle': 'Preparation Protocol for the First Pediatric Dental Visit', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.', 'orgStudyIdInfo': {'id': 'bagattoni1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'Information Booklet prior to the dental visit', 'interventionNames': ['Behavioral: Information Booklet']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no information prior to the dental visit'}], 'interventions': [{'name': 'Information Booklet', 'type': 'BEHAVIORAL', 'description': 'Information Booklet prior to the dental visit', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40125', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Simone Bagattoni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bologna University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Simone Bagattoni', 'investigatorAffiliation': 'University of Bologna'}}}}