Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05039502
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2021-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Releasing of Inflammatory Mediators During Retreatment of Root Canals
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': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of inflammatory mediator level', 'timeFrame': '24 hours', 'description': 'The samples were collected from periapical exudate at the end of the root canal retreatment procedure. The samples were analyzed with ELISA method and change of inflammatory mediator levels were evaluated in pg/ml.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Response', 'Root Canal Infection']}, 'referencesModule': {'references': [{'pmid': '36856848', 'type': 'DERIVED', 'citation': 'Kasikci S, Turker SA, Guven B. Effect of different retreatment files using different kinematics on the release of inflammatory mediators in root canal retreatment of single-rooted teeth: a randomized clinical trial. Clin Oral Investig. 2023 Jun;27(6):3189-3196. doi: 10.1007/s00784-023-04930-6. Epub 2023 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.The aim of this thesis study is to evaluate the effect of ProTaper Universal Retreatment (PTUR), Reciproc blue and XP-endo Finisher R file systems, which are used in the removal of root canal filling materials during retreatment with different motion kinetics on the release of Substance P, Calcitonin Gene-Related Peptide (CGRP), IL-6 and IL-10 inflammatory mediators in the periapical region', 'detailedDescription': 'Seventy-five individuals with asymptomatic and chronic apical periodontitis teeth with retreatment indication were included in the study. Individuals were randomly divided into three groups according to the file system used to remove root canal filling materials (n = 25): ProTaper Universal Retreatment, Reciproc blue and XP-endo Finisher R.After the removal of the previous root canal filling materials, reshaping and disinfection of the root canals, periapical fluid samples were taken from the root tip of the teeth in all three groups. The amount of Substance P, CGRP, IL-6 and IL-10 mediators that cause pain, swelling and flare-up in periapical fluid samples were measured by ELISA test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had single root canal treated teeth with chronic periapical lesion\n\nExclusion Criteria:\n\n* Patients who are immunocompromised\n* Patients under antibiotic or analgesic medication'}, 'identificationModule': {'nctId': 'NCT05039502', 'briefTitle': 'Releasing of Inflammatory Mediators During Retreatment of Root Canals', 'organization': {'class': 'OTHER', 'fullName': 'Bulent Ecevit University'}, 'officialTitle': 'The Effect of Different File Systems Used in Retreatment on the Release of Inflammatory Mediators', 'orgStudyIdInfo': {'id': '2020-27194235-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retreatment system using in rotational motion', 'description': 'Previous root canal filling materials were removed with D1-D2-D3 retreatment files with using an endodontic motor in rotational motion', 'interventionNames': ['Other: Protaper Universal Retreatment']}, {'type': 'EXPERIMENTAL', 'label': 'Retreatment system using in reciprocal motion', 'description': 'Previous root canal filling materials were removed with Reciproc 25 file with using an endodontic motor in reciprocal motion', 'interventionNames': ['Other: Reciproc']}, {'type': 'EXPERIMENTAL', 'label': 'Retreatment system using in additional rotational motion', 'description': 'Previous root canal filling materials were removed with XP-endo finisher r file with using an endodontic motor in rotational motion', 'interventionNames': ['Other: XP-Endo finisher R']}], 'interventions': [{'name': 'Protaper Universal Retreatment', 'type': 'OTHER', 'description': 'D1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor', 'armGroupLabels': ['Retreatment system using in rotational motion']}, {'name': 'Reciproc', 'type': 'OTHER', 'description': 'R25 retratment files were used with X-Smart endomotor in reciprocal motion', 'armGroupLabels': ['Retreatment system using in reciprocal motion']}, {'name': 'XP-Endo finisher R', 'type': 'OTHER', 'description': 'XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor', 'armGroupLabels': ['Retreatment system using in additional rotational motion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zonguldak', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Dentistry of Bulent Ecevit University', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}], 'overallOfficials': [{'name': 'Sevinç Aktemur Türker', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bulent Ecevit University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sevinç Aktemur Türker', 'investigatorAffiliation': 'Bulent Ecevit University'}}}}