Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT04277520
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2020-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Pain Assessment After Using Different Kinematics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012390', 'term': 'Root Canal Therapy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-24', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'monitoring the change in postoperative pain following root canal treatment', 'timeFrame': '72 hours', 'description': 'At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain'}], 'secondaryOutcomes': [{'measure': '6-hour post operative pain assessment', 'timeFrame': '6 hours', 'description': 'At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 6 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain'}, {'measure': '12-hour post operative pain assessment', 'timeFrame': '12 hours', 'description': 'At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 12 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain'}, {'measure': '24-hour post operative pain assessment', 'timeFrame': '24 hours', 'description': 'At the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain after 24 hours, following endodontic treatment with 0 representing no pain and 10 representing the most severe pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Root Canal Therapy']}, 'referencesModule': {'references': [{'pmid': '23741536', 'type': 'BACKGROUND', 'citation': 'Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.', 'detailedDescription': 'Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, with 0 representing no pain and 10 representing the most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h following endodontic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Medically free patients with good health.\n2. Patient's age between 18\\_50\n3. Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis\n4. Positive patient's acceptance for participation in the study\n\nExclusion Criteria:\n\n* Root resorption\n* Non restorable teeth.\n* Pregnancy.\n* Systematic disease as hypertension ,diabetes .\n* Psychologically disturbance.\n* Need for prophylactic antibiotics"}, 'identificationModule': {'nctId': 'NCT04277520', 'briefTitle': 'Postoperative Pain Assessment After Using Different Kinematics', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Postoperative Pain Assessment After Using Different Kinematics During Endodontic Instrumentation (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'ASFD-ENDO-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continous rotation', 'description': 'instrumentation was done in continuous rotation motion', 'interventionNames': ['Procedure: Root canal therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reciprocation', 'description': 'instrumentation was done in reciprocation motion', 'interventionNames': ['Procedure: Root canal therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adaptive motion', 'description': 'instrumentation was done in adaptive motion', 'interventionNames': ['Procedure: Root canal therapy']}], 'interventions': [{'name': 'Root canal therapy', 'type': 'PROCEDURE', 'description': 'Different types of instrumentation motions during root canal therapy', 'armGroupLabels': ['Adaptive motion', 'Continous rotation', 'Reciprocation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Ainshams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Hashem, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dentistry, Ain Shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohamed Mokhtar Nagy', 'investigatorAffiliation': 'Ain Shams University'}}}}