Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT05475795
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C498115', 'term': 'Metapex'}, {'id': 'C098568', 'term': 'Endoflas F.S.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-07-24', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain.', 'timeFrame': 'after one day and after one week .', 'description': 'Measuring post operative pain after pulpectomy with two different obturation materials using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.', 'detailedDescription': 'The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:\n\nClinical:\n\n1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.\n2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).\n3. Presence of at least one primary molar with deep carious lesion.\n4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.\n\nRadiographic:\n\n1. Extensive caries approaching to the pulp.\n2. Presence of at least two-thirds of root length.\n\nExclusion Criteria:\n\n* A child\'s tooth with any of the following criteria:\n\nClinical findings:\n\n1. History of spontaneous unprovoked toothache.\n2. Extensive crown destruction that preclude coronal restoration.\n3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".\n4. History of administering analgesics 12 hours before tooth obturation.\n\nRadiographic findings:\n\n1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.\n2. Presence of pathological internal/external root resorption.\n3. Absence of underlying permanent successor.'}, 'identificationModule': {'nctId': 'NCT05475795', 'briefTitle': 'Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '576-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metapex group', 'description': 'Obturation of primary molars with calcium hydroxide and iodoform paste', 'interventionNames': ['Other: Metapex', 'Other: Endoflas']}, {'type': 'EXPERIMENTAL', 'label': 'Endoflas group', 'description': 'Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste', 'interventionNames': ['Other: Metapex', 'Other: Endoflas']}], 'interventions': [{'name': 'Metapex', 'type': 'OTHER', 'description': 'obturation of root canals of primary molars with Metapex', 'armGroupLabels': ['Endoflas group', 'Metapex group']}, {'name': 'Endoflas', 'type': 'OTHER', 'description': 'obturation of root canals of primary molars with Endoflas', 'armGroupLabels': ['Endoflas group', 'Metapex group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nada M Hassan', 'role': 'CONTACT', 'email': 'nadooshaa66@gmail.com', 'phone': '00201116889844'}], 'facility': 'Nada Mohamed Hassan Saied', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Osama S Gad El-Hak', 'role': 'CONTACT', 'email': 'osama.seif@mu.edu.eg', 'phone': '00201023449797'}], 'overallOfficials': [{'name': 'Osama S Gad El-Hak, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Dentistry Department, Faculty of Dentistry, Minia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate student at Faculty of Dentistry Minia University', 'investigatorFullName': 'Nada Mohamed Hassan', 'investigatorAffiliation': 'Minia University'}}}}