Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 3:59 AM
Study NCT ID:
NCT07019792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain and Bacterial Reduction in Oval Canals After Instrumentation With Different Noval Rotary Files Systems
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment', 'description': 'Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome.\n\n0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain'}, {'measure': 'Bacterial count reduction', 'timeFrame': 'Sample will be collected before and directly after canal prepeartion', 'description': 'Bacterial count sample will be collected before and after canal prepeartion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post operative pain', 'Protaper Ultimate', 'Hyflex EDM', 'XP rsie', 'TruNatomy', 'Bacterial', 'Oval canal'], 'conditions': ['Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems', 'Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems']}, 'descriptionModule': {'briefSummary': "Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal", 'detailedDescription': 'One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically fit\n* Age ranges from 18-65 year\n* Restorable teeth\n* Necrotic teeth and symptoms free\n* Lower premolars teeth (single canal posterior teeth)\n* Necrotic pulps\n\nExclusion Criteria:\n\n* Medically compromised\n* Non-restorable teeth\n* Open apex canal\n* The past 12-hour history of analgesic intake before treatment.\n* Patients with a history of antibiotics intake in the last 3 months before treatment.\n* Pregnant females.\n* Symptomatic patient.\n* Pulpal diagnosis is not necrotic pulp.\n* Retreatment cases'}, 'identificationModule': {'nctId': 'NCT07019792', 'briefTitle': 'Postoperative Pain and Bacterial Reduction in Oval Canals After Instrumentation With Different Noval Rotary Files Systems', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah University Hospital'}, 'officialTitle': 'Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial', 'orgStudyIdInfo': {'id': '20230408'}, 'secondaryIdInfos': [{'id': '20230408', 'type': 'OTHER_GRANT', 'domain': 'Jordan University of Science and Technology'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multifile system: Protaper Ultimate', 'interventionNames': ['Other: Protaper ultimate']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple files systems:TruNatomy', 'interventionNames': ['Other: Truanatomy file system']}, {'type': 'EXPERIMENTAL', 'label': 'Single file system: Hyflex EDM', 'interventionNames': ['Other: Hyflex EDM']}, {'type': 'EXPERIMENTAL', 'label': 'Single file system: Xp shaper rise', 'interventionNames': ['Other: Xp shaper rise']}], 'interventions': [{'name': 'Protaper ultimate', 'type': 'OTHER', 'description': 'Using Protaper Ultimate file system for canal preperation', 'armGroupLabels': ['Multifile system: Protaper Ultimate']}, {'name': 'Truanatomy file system', 'type': 'OTHER', 'description': 'Using Truanatomy file system for canal preperation', 'armGroupLabels': ['Multiple files systems:TruNatomy']}, {'name': 'Hyflex EDM', 'type': 'OTHER', 'description': 'Using Hyflex file system for canal preperation', 'armGroupLabels': ['Single file system: Hyflex EDM']}, {'name': 'Xp shaper rise', 'type': 'OTHER', 'description': 'Using XPshaper rise system for canal preperation', 'armGroupLabels': ['Single file system: Xp shaper rise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Ruba Mustafa', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor associate', 'investigatorFullName': 'Ruba Mustafa', 'investigatorAffiliation': 'King Abdullah University Hospital'}}}}