Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-20 @ 7:20 PM
Study NCT ID:
NCT02621034
Status:
COMPLETED
Last Update Posted:
2016-06-06
First Post:
2015-11-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marty_zl@yahoo.com', 'phone': '+989215257093', 'title': 'Seyed Roholla Havaei', 'organization': 'Zahedan university of medical sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious and Other \\[Not Including Serious\\] Adverse Events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'K-file hand instrumentation\n\nControl: K-file hand instrumentation', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reciproc', 'description': 'rotary reciprocating protocol\n\nReciproc: reciprocating rotary instrument', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'One Shape', 'description': 'one shape continuous rotation protocol\n\nOne shape: full rotation protocol', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'K-file hand instrumentation\n\nControl: K-file hand instrumentation'}, {'id': 'OG001', 'title': 'Reciproc', 'description': 'rotary reciprocating protocol\n\nReciproc: reciprocating rotary instrument'}, {'id': 'OG002', 'title': 'One Shape', 'description': 'one shape continuous rotation protocol\n\nOne shape: full rotation protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reciproc', 'description': 'rotary reciprocating protocol\n\nReciproc: reciprocating rotary instrument'}, {'id': 'OG001', 'title': 'One Shape', 'description': 'one shape continuous rotation protocol\n\nOne shape: full rotation protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'K-file hand instrumentation\n\nControl: K-file hand instrumentation'}, {'id': 'OG001', 'title': 'Reciproc', 'description': 'rotary reciprocating protocol\n\nReciproc: reciprocating rotary instrument'}, {'id': 'OG002', 'title': 'One Shape', 'description': 'one shape continuous rotation protocol\n\nOne shape: full rotation protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'k File', 'description': 'hand instrumentation\n\nk file: hand instrumentation'}, {'id': 'FG001', 'title': 'Reciproc', 'description': 'rotary reciprocating protocol\n\nReciproc: reciprocating rotary instrument'}, {'id': 'FG002', 'title': 'One Shape', 'description': 'one shape continuous rotation protocol\n\nOne shape: full rotation protocol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'K-file hand instrumentation\n\nControl: K-file hand instrumentation'}, {'id': 'BG001', 'title': 'Reciproc', 'description': 'rotary reciprocating protocol\n\nReciproc: reciprocating rotary instrument'}, {'id': 'BG002', 'title': 'One Shape', 'description': 'one shape continuous rotation protocol\n\nOne shape: full rotation protocol'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '31.7', 'spread': '12.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tooth type', 'classes': [{'title': 'Maxillary molars', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Mandibular molars', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-29', 'studyFirstSubmitDate': '2015-11-29', 'resultsFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-29', 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval', 'timeFrame': '6 hours', 'description': 'The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).'}, {'measure': 'Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals', 'timeFrame': '72 hours'}, {'measure': 'Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Root canal treatment', 'pain', 'endodontic instruments'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.', 'detailedDescription': 'Comparison of the post operative pain with two rotary systems including Reciproc and One shape.\n\nConfounding factors were neutralized and the rotary systems were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systematically healthy patients\n* First or second molars with irreversible pulpitis without periapical pathosis.\n* Single visit endodontic treatment\n\nExclusion Criteria:\n\n* Root canal retreatment\n* Pregnancy\n* The presence of a difficult root canal anatomy\n* Internal or external resorption\n* Teeth with open apices\n* Any accident of complication occurred during treatment\n* Presence of periapical lesion, abscess or sinus tract'}, 'identificationModule': {'nctId': 'NCT02621034', 'briefTitle': 'Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems', 'organization': {'class': 'OTHER', 'fullName': 'Zahedan University of Medical Sciences'}, 'officialTitle': 'Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SRH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'K-file hand instrumentation', 'interventionNames': ['Procedure: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Reciproc', 'description': 'rotary reciprocating protocol', 'interventionNames': ['Procedure: Reciproc']}, {'type': 'EXPERIMENTAL', 'label': 'One shape', 'description': 'one shape continuous rotation protocol', 'interventionNames': ['Procedure: One shape']}], 'interventions': [{'name': 'Control', 'type': 'PROCEDURE', 'description': 'K-file hand instrumentation', 'armGroupLabels': ['Control']}, {'name': 'Reciproc', 'type': 'PROCEDURE', 'description': 'reciprocating rotary instrument', 'armGroupLabels': ['Reciproc']}, {'name': 'One shape', 'type': 'PROCEDURE', 'description': 'full rotation protocol', 'armGroupLabels': ['One shape']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zahedan', 'country': 'Iran', 'facility': 'Zahedan Dental School', 'geoPoint': {'lat': 29.4963, 'lon': 60.8629}}], 'overallOfficials': [{'name': 'Eshagh Ali Saberi, DDS,MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the department of Endodontics, Zahedan university of medical sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zahedan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}