Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-03 @ 7:41 AM
Study NCT ID:
NCT05883566
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2023-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Dental Pain Response in Children
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': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2023-05-21', 'studyFirstSubmitQcDate': '2023-05-21', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': 'immediately after completion of the treatment within 60 seconds', 'description': 'Analysis of pain after the treatment pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Anxiety']}, 'referencesModule': {'references': [{'pmid': '40753526', 'type': 'DERIVED', 'citation': 'Abbasi H, Saini RS, Binduhayyim RIH, Kuruniyan MS, Mosaddad SA, Heboyan A. Comparison of behavioural, physiological, and self-reported pain responses in Pakistani children with dental pain: a descriptive cross-sectional study. Eur Arch Paediatr Dent. 2025 Dec;26(6):1181-1192. doi: 10.1007/s40368-025-01090-x. Epub 2025 Aug 3.'}]}, 'descriptionModule': {'briefSummary': "Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study.\n* Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included.\n* Consent: Informed consent must be obtained from the child and their parents or guardians before the study.\n\nExclusion Criteria:\n\n* Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression.\n* Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.'}, 'identificationModule': {'nctId': 'NCT05883566', 'briefTitle': 'Comparison of Dental Pain Response in Children', 'organization': {'class': 'OTHER', 'fullName': 'Altamash Institute of Dental Medicine'}, 'officialTitle': 'Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain', 'orgStudyIdInfo': {'id': 'Dental Pain in children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'behaviour', 'interventionNames': ['Behavioral: experimental']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'experimental', 'type': 'BEHAVIORAL', 'description': "During the procedure, the chairside assistant can capture video recordings of the child's behavior and facial expressions. These videos can be later reviewed by a trained observer who can evaluate the child's pain experience", 'armGroupLabels': ['behaviour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Hira', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75500', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Hira Danish', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altamash Institute of Dental Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Hira Abbasi', 'investigatorAffiliation': 'Altamash Institute of Dental Medicine'}}}}