Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-06 @ 3:11 PM
Study NCT ID:
NCT06286995
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2024-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], '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'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012390', 'term': 'Root Canal Therapy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "A) Sequence generation: was done using random sequence number generated by computer software B) Allocation concealment Mechanism:folded,numbered papers were placed in tightly sealed envelopes containing patients' coding"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was designed to be randomized,single- blinded, single-center clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-24', 'studyFirstSubmitDate': '2024-02-24', 'studyFirstSubmitQcDate': '2024-02-24', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of post operative pain using 10-cm visual analogue scale ( VAS)', 'timeFrame': 'After 6 hours,24 hours, 48 hours and finally 72 hours', 'description': '10-cm visual analogue scale (VAS) questionnaire.each patient reported their level of pain as follow: 0 no pain,1-3 mild pain,4-6 moderate pain,7-9 severe pain and 10 the worst pain'}], 'secondaryOutcomes': [{'measure': 'Level of inflammatory mediators substance P in apical fluid samples', 'timeFrame': 'Preoperatively ( after working length determination) and before obturation after 3days', 'description': "Sample were obtained by paper point size 25passing 2mm beyond the apex where they were soaked in the periapical interstitial fluid for 1minute .four mm from tip of paper point we're cut and dropped into 1,5ml Eppendorf tubes ( Swanscombe,UK) with 1ml of phosphate buffered saline,then restored at -80 to be measured by ELISA test"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post operative pain', 'Substance P', 'Apical periodontitis', 'Trunatomy file', 'Edgeendo x7 file'], 'conditions': ['Post Operative Pain', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '21092809', 'type': 'BACKGROUND', 'citation': 'Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.'}, {'pmid': '37205884', 'type': 'BACKGROUND', 'citation': 'Valliappan CT, Rahul B, Gabriel EM, Sherwood IA, Gutmann JL, Amaechi BT, Burhanuddin Mohammed OF. Evaluation of postoperative pain with new heat-treated rotary and reciprocating nickel-titanium files: A randomized controlled clinical trial. J Conserv Dent. 2023 Mar-Apr;26(2):170-175. doi: 10.4103/jcd.jcd_566_22. Epub 2023 Mar 16.'}], 'seeAlsoLinks': [{'url': 'http://dsu.journals.ekb.eg/article_192084.html', 'label': 'Worked on inflammatory mediators in similar matter'}]}, 'descriptionModule': {'briefSummary': 'The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS)', 'detailedDescription': "Patients : 20 patients with symptomatic apical periodontitis related to mandibular premolars were selected.after proper anathesia, Access cavity was ppreformed.The working length measured using apex locator.chemomechanical preparation was done .for trunatomy file group ,using file sequence according to manufacture's instructions until medium one .for edgeendo group ,using file sequence also according to manufacture's instructions until file size 35 taper4.Apical fluid samples was collected by paper point from the both preoperatively and before obturation and also pain was assessed pre and post opertively.finally,the root canal were filled by gutta-percha and resin based sealer.the access cavity was restored by glass ionomer restoration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnoses of apical periodontitis related to single-rooted mandibular premolars\n* no evidence of excessive mobility\n\nExclusion Criteria:\n\n* presence of any systemic disease or allergic reaction\n* Incompletely formed root\n* Previously Endodontically treated teeth'}, 'identificationModule': {'nctId': 'NCT06286995', 'briefTitle': 'Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '6280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trunatomy file group', 'description': 'Using trunatomy file for chemomechanical preparation for root canal of mandibular premolars', 'interventionNames': ['Procedure: Chemomechanical preparation for root canals']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Edgeendo x7 file group', 'description': 'Using edgeendo x7 file for chemomechanical preparation for root canal of mandibular premolars', 'interventionNames': ['Procedure: Chemomechanical preparation for root canals']}], 'interventions': [{'name': 'Chemomechanical preparation for root canals', 'type': 'PROCEDURE', 'otherNames': ['Root canal treatment'], 'description': 'After working length determination ,root canal preparation was made by two different NiTi File systems to both group ( the first group using Trunatomy file and the second one using edgeendo x7 file) and assessment of pain was made preoperatively and postoperatively and also apical fluid samples', 'armGroupLabels': ['Edgeendo x7 file group', 'Trunatomy file group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Maram F Obeid, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of dentistry, Ain shams university'}]}, 'ipdSharingStatementModule': {'url': 'http://asmj.journal.ekb.eg', 'infoTypes': ['SAP'], 'timeFrame': '2025, available for a year', 'ipdSharing': 'YES', 'description': 'Detailed statistical analysis plan', 'accessCriteria': 'Review the purpose of request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bachelor degree in Dental Medicine and Surgery,May 2017', 'investigatorFullName': 'Fatma Essam Badr El-din, Bachelor', 'investigatorAffiliation': 'Ain Shams University'}}}}