Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-02-27 @ 10:06 AM
Study NCT ID:
NCT04119661
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2019-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2019-10-06', 'studyFirstSubmitQcDate': '2019-10-06', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain using a pain-measuring scale', 'timeFrame': '4 hours', 'description': 'Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment'}, {'measure': 'Postoperative pain using a pain-measuring scale', 'timeFrame': '12 hours', 'description': 'Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment'}, {'measure': 'Postoperative pain using a pain-measuring scale', 'timeFrame': '24 hours', 'description': 'Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment'}, {'measure': 'Postoperative pain using a pain-measuring scale', 'timeFrame': '48 hours', 'description': 'Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Symptomatic Irreversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '20647083', 'type': 'BACKGROUND', 'citation': 'Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.'}, {'pmid': '27248848', 'type': 'BACKGROUND', 'citation': 'Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.', 'detailedDescription': 'The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 16-65 year old.\n2. Medically free.\n3. Mandibular posterior teeth with symptomatic irreversible pulpitis.\n4. No sex predilection\n\nExclusion Criteria:\n\n1. Pregnant females.\n2. History of allergy to any medication used in the study.\n3. Preoperative premedication less than 6 hours before procedure.\n4. Cracked teeth and teeth with badly-decayed crowns.'}, 'identificationModule': {'nctId': 'NCT04119661', 'briefTitle': 'Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ENDO-CU-2012-7-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Max-i-Probe', 'interventionNames': ['Device: Max-i-Probe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NaviTip', 'interventionNames': ['Device: NaviTip']}], 'interventions': [{'name': 'Max-i-Probe', 'type': 'DEVICE', 'description': 'Using Max-i-Probe as endodontic needle during syringe irrigation', 'armGroupLabels': ['Max-i-Probe']}, {'name': 'NaviTip', 'type': 'DEVICE', 'description': 'Using NaviTip as endodontic needle during syringe irrigation', 'armGroupLabels': ['NaviTip']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Suzan Amin, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mohamed El-Bayoumi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Suzan AW Amin', 'investigatorAffiliation': 'Cairo University'}}}}