Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03412318
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2018-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-20', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': '2 days', 'description': 'Post-operative pain assessed after treatment using the NRS pain scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pulpitis']}, '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': 'A study to comparatively evaluate the post operative pain between root canal preparation by reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth with acute irreversible pulpits.', 'detailedDescription': 'Teeth with symptomatic irreversible pulpitis are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment after using Twisted files or M-pro files. The treatment is done in single visit. The postoperative pain is then assessed using the Numerical Rating Scale 6,12, 24 and 48 hours post-instrumentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in good health (American Society of Anesthesiologists Class II or higher).\n* Patients having symptomatic irreversible pulpitis in their single rooted teeth.\n* Age range is between 20 and 60 years.\n* Patients who can understand numerical rating scale (NRS).\n* Patients able to sign informed consent.\n\nExclusion Criteria:\n\n* Patients with positive percussion test.\n* Patients having history of necrosis with or without apical pathosis.\n* Patients have sinus tract or fistula extra oral or intraoral.\n* Pregnant or mentally retarded patients.\n* Teeth with grade 2 or 3 mobility.'}, 'identificationModule': {'nctId': 'NCT03412318', 'briefTitle': 'Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment: A Blinded Randomized Clinical Trial Therapeutic Study.', 'orgStudyIdInfo': {'id': 'TF vs Mpro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Twisted file', 'description': 'Use of twisted file during cleaning and shaping of root canals', 'interventionNames': ['Device: Twisted file']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mpro', 'description': 'Use of Mpro file during cleaning and shaping of root canals', 'interventionNames': ['Device: Mpro']}], 'interventions': [{'name': 'Twisted file', 'type': 'DEVICE', 'description': 'Use of twisted file during cleaning and shaping of root canals', 'armGroupLabels': ['Twisted file']}, {'name': 'Mpro', 'type': 'DEVICE', 'description': 'Use of Mpro during cleaning and shaping of root canals', 'armGroupLabels': ['Mpro']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmad Almorad', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmad Abdul Aziz Almorad', 'investigatorAffiliation': 'Cairo University'}}}}