Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 12:06 PM
Study NCT ID:
NCT05450003
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2022-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-13', 'mcpReleaseN': 3, 'releaseDate': '2024-07-23'}], 'estimatedResultsFirstSubmitDate': '2024-07-23'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'the study will evaluate 3 groups of patients each consists of 10 participants receiving different type of irrigation activation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2022-06-18', 'studyFirstSubmitQcDate': '2022-07-04', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'irrigant penetration depth', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'measurement of irrigant penetration depth using radioaque media and digital radiography'}, {'measure': 'postoperative pain', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum pain'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Irrigation Activation']}, 'referencesModule': {'references': [{'pmid': '41188367', 'type': 'DERIVED', 'citation': 'Elgazzar YFK, Darrag AM, Attia DAM. Effect of XP-endo Finisher and EDDY activation on post-operative pain after single-visit endodontic treatment: a randomized controlled clinical trial. Sci Rep. 2025 Nov 4;15(1):38476. doi: 10.1038/s41598-025-23628-1.'}]}, 'descriptionModule': {'briefSummary': 'Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic vital/non vital teeth requiring root canal treatment.\n* Teeth with sound periodontal apparatus.\n* Teeth without pus or inflammatory exudates draining through the canal.\n* Teeth without anatomic variations.\n* Teeth with sinus tract.\n* Teeth without history of trauma.\n* Patients not on analgesics or sedative medication prior to root canal therapy\n\nExclusion Criteria:\n\n* • Patients with any systemic diseases.\n\n * Pregnant or lactating patients.\n * Immunocompromised patients.\n * Apparently thin roots in which apical preparation with #40 file would be overzealous.\n * Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).\n * Teeth with calcified canals.\n * Patients with acute apical periodontitis, acute apical abscess, and weeping canals.\n * Necrotic painful teeth with the absence of sinus tract for drainage.'}, 'identificationModule': {'nctId': 'NCT05450003', 'briefTitle': 'Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth Into Root Canals and on Post-Operative Pain After Single-Visit Endodontic Treatment', 'orgStudyIdInfo': {'id': 'Elgazzar YF1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'xp endo finisher file', 'interventionNames': ['Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation']}, {'type': 'OTHER', 'label': 'new sonic EDDY system', 'interventionNames': ['Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation']}, {'type': 'OTHER', 'label': 'syringe needle irrigation', 'interventionNames': ['Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation']}], 'interventions': [{'name': 'Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation', 'type': 'DEVICE', 'description': 'irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation', 'armGroupLabels': ['new sonic EDDY system', 'syringe needle irrigation', 'xp endo finisher file']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Administrator of endodontics_ faculty of dentistry _Tanta university', 'investigatorFullName': 'Yara Fawzy Kotb Elgazzar', 'investigatorAffiliation': 'Tanta University'}}}}