Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT04616469
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2020-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-29', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain using visual analogue scale', 'timeFrame': 'at 24 hours post treatment', 'description': 'pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible'}, {'measure': 'Post operative pain using visual analogue scale', 'timeFrame': 'at 48 hours post treatment', 'description': 'pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible'}, {'measure': 'Post operative pain using visual analogue scale', 'timeFrame': 'at 72 hours post treatment', 'description': 'pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible'}, {'measure': 'Post operative pain using visual analogue scale', 'timeFrame': 'at 1 week post treatment', 'description': 'pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible'}], 'secondaryOutcomes': [{'measure': 'operative torque generated during instrumentation', 'timeFrame': 'during treatment', 'description': 'real time operative torque exerted on the instrument through out the shaping process and until the instrument reaches the full working length will be measured using a torque measuring motor in real time'}, {'measure': 'time required for the instrument to reach the full working length', 'timeFrame': 'during treatment', 'description': 'time required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '31891973', 'type': 'BACKGROUND', 'citation': 'Gambarini G, Galli M, Seracchiani M, Di Nardo D, Versiani MA, Piasecki L, Testarelli L. In Vivo Evaluation of Operative Torque Generated by Two Nickel-Titanium Rotary Instruments during Root Canal Preparation. Eur J Dent. 2019 Oct;13(4):556-562. doi: 10.1055/s-0039-1698369. Epub 2019 Dec 31.'}, {'pmid': '27790254', 'type': 'BACKGROUND', 'citation': "Zand V, Milani AS, Hassani Dehkharghani A, Rahbar M, Tehranchi P. Treatment of Necrotic Teeth Using Two Engine-Driven Systems and Patient's Postoperative Pain: A Double-Blind Clinical Trial. Iran Endod J. 2016 Fall;11(4):267-272. doi: 10.22037/iej.2016.3."}, {'pmid': '40684114', 'type': 'DERIVED', 'citation': 'Al-Mosalmy TA, El-Far HM, Gomaa MM, Morsy DA. Impact of root canal shaping using TruNatomy on postoperative pain and operative torque generation: a randomized clinical trial. BMC Oral Health. 2025 Jul 19;25(1):1222. doi: 10.1186/s12903-025-06418-z.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:\n\n* Post operative pain: incidence and intensity\n* Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor\n* Time needed for the instruments to reach to the full working length'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.\n* Age between 30-60 years old.\n* Males \\& Females.\n* Patients' acceptance for participating in the trial through an informed consent\n* Maxillary permanent premolar teeth:\n\n * Diagnosed clinically and radiographically with pulp necrosis\n * With or without periapical radiolucency\n * Negative response of pulp tissue to thermal and electric pulp tester\n * Possessing two independent roots each having a type I canal\n * Patent canals with no internal calcification or resorptive lesions\n * Fully formed roots\n * Root curvatures less than 30\n\nExclusion Criteria:\n\n* Patient with contributory medical condition\n* Badly destructed teeth\n* Patients with pre-operative pain\n* Patients having significant systemic disorders\n* Patients with two or more adjacent teeth requiring root canal therapy\n* Patients who had received antibiotics in the last month\n* Teeth presenting with:\n\n * Positive response to thermal or electric pulp tester\n * History of trauma or previous endodontic treatment\n * Immature or open apices\n * Association with acute periapical abscess and swelling or fistulous tract\n * Fused roots at any level\n * Canals larger than size 15# K-file\n * Periodontonal/ endodontic lesions\n * Mobility higher than grade I\n * Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.\n * Severe root curvature (\\>30)"}, 'identificationModule': {'nctId': 'NCT04616469', 'briefTitle': 'Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ENDO:3-3-5 (8-10-2020)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Root canal treatment using RaCe rotary system', 'description': 'Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity', 'interventionNames': ['Procedure: Root canal treatment using race rotary instruments']}, {'type': 'EXPERIMENTAL', 'label': 'Root canal treatment using TruNatomy rotary system', 'description': 'Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity', 'interventionNames': ['Procedure: Root canal treatment using TruNaomy rotary files']}], 'interventions': [{'name': 'Root canal treatment using TruNaomy rotary files', 'type': 'PROCEDURE', 'description': 'Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system', 'armGroupLabels': ['Root canal treatment using TruNatomy rotary system']}, {'name': 'Root canal treatment using race rotary instruments', 'type': 'PROCEDURE', 'description': 'Race rotary files will be used for the process of cleaning and shaping of the root canal system', 'armGroupLabels': ['Root canal treatment using RaCe rotary system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Tarek Ali El Mosalamy', 'investigatorAffiliation': 'Cairo University'}}}}