Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-30 @ 10:22 AM
Study NCT ID:
NCT04338633
Status:
UNKNOWN
Last Update Posted:
2020-04-08
First Post:
2020-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Pain Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531021', 'term': 'UltraCal XS'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in post operative pain (Visual Analogue Scale)', 'timeFrame': 'Intrappointment at 4,24,48,72 and 96 hours ]', 'description': 'Numerical (0-10)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effects of the Elements']}, 'referencesModule': {'references': [{'pmid': '23657409', 'type': 'BACKGROUND', 'citation': 'Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.'}]}, 'descriptionModule': {'briefSummary': 'Recruited patients with necrotic pulp after application of conventional calcium hydroxide paste are assigned to group, Calcium hydroxide nanoparticle group and Combined Calcium hydroxide with silver nanoparticle group and record postoperative pain afterwards.', 'detailedDescription': 'The investigator will recruit patients who are found eligible to the criteria, conventional calcium hydroxide paste , Calcium hydroxide nanoparticle and Combined Calcium hydroxide with silver nanoparticle . After 48 hours, patients will be randomly assigned to removal of intracanal medication\n\nAfter the visit, patients will be asked to record post operative pain by Numerical Rating Scale)in a given sheet'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Medically free patients.\n\n * Patient's age between 25-50 years.\n * Sex includes both male and female.\n * Radiographic evidence of a periapical radiolucent lesion associated with tooth.\n * Necrotic pulp as indicated by thermal pulp testing.\n * No history of previous endodontic treatment of the tooth.\n\nExclusion Criteria:\n\n* • Teeth with unfavorable conditions for rubber-dam application.\n\n * Teeth with acute periapical abscesses swelling.\n * Medically compromised patients.\n * Immature teeth with open apices.\n * Multi rooted teeth.\n * Pregnant women."}, 'identificationModule': {'nctId': 'NCT04338633', 'briefTitle': 'Post-operative Pain Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Post-operative Pain Reduction After Application of Three Intracanal Medicament Within Necrotic Root Canals and Pulp', 'orgStudyIdInfo': {'id': '314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional calcium hydroxide paste', 'description': 'Application of Conventional calcium hydroxide paste', 'interventionNames': ['Drug: Conventional calcium hydroxide paste']}, {'type': 'EXPERIMENTAL', 'label': 'Calcium hydroxide nanoparticle', 'description': 'Application of Calcium hydroxide nanoparticle', 'interventionNames': ['Drug: Calcium hydroxide nanoparticle']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Calcium hydroxide with silver nanoparticle', 'description': 'Application of Combined Calcium hydroxide with silver nanoparticle', 'interventionNames': ['Drug: Combined Calcium hydroxide with silver nanoparticle']}], 'interventions': [{'name': 'Conventional calcium hydroxide paste', 'type': 'DRUG', 'otherNames': ['Ultracal'], 'description': 'Conventional calcium hydroxide paste (Ultracal) will be removed in second visit.', 'armGroupLabels': ['Conventional calcium hydroxide paste']}, {'name': 'Calcium hydroxide nanoparticle', 'type': 'DRUG', 'description': 'Calcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit.', 'armGroupLabels': ['Calcium hydroxide nanoparticle']}, {'name': 'Combined Calcium hydroxide with silver nanoparticle', 'type': 'DRUG', 'description': 'Combined Calcium hydroxide with silver nanoparticle will be removed in second visit.', 'armGroupLabels': ['Combined Calcium hydroxide with silver nanoparticle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Reham Hassan, Assoc Prof', 'role': 'CONTACT', 'email': 'reham-hassan@live.com', 'phone': '+201001542529'}], 'facility': 'Faculty of Dentistry, Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Mohamed Salah Hegazi', 'role': 'CONTACT', 'email': 'mshegazi2006@gmail.com', 'phone': '+201224014179'}, {'name': 'Reham Hassan, Assoc Prof', 'role': 'CONTACT', 'email': 'reham-hassan@live.com', 'phone': '+201001542529'}], 'overallOfficials': [{'name': 'Magdy Mohamed Aly, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dean of Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD Candidate - Endodontic Department- Faculty of Dentistry', 'investigatorFullName': 'Mohamed Salah Mohamed Fahmy', 'investigatorAffiliation': 'Minia University'}}}}