Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-06 @ 10:10 AM
Study NCT ID:
NCT06339905
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline postoperative pain at 1 week', 'timeFrame': '1,2,3 and 7 days', 'description': 'Pain was measured using a Verbal Rating Scale with 4 levels, as follows: 0, no pain; 1, slight pain (mild discomfort, no treatment needed); 2, moderate pain (pain required analgesics for relief); 3, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit) and Wong Baker Face Scale with six different facial expression. Patients were provided forms and asked to record preoperative pain as well as pain at 1,2,3 and 7 days postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.'}, {'measure': 'change from baseline periapical index at 1 year', 'timeFrame': 'Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]', 'description': 'Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features.\n\nTreatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic apical periodontitis', 'irrigation activation', 'periapical index', 'postoperative pain', 'treatment outcome', 'periapical health'], 'conditions': ['Periapical Periodontitis', 'Root Canal Infection']}, 'referencesModule': {'references': [{'pmid': '9206419', 'type': 'BACKGROUND', 'citation': 'Orstavik D. Time-course and risk analyses of the development and healing of chronic apical periodontitis in man. Int Endod J. 1996 May;29(3):150-5. doi: 10.1111/j.1365-2591.1996.tb01361.x.'}, {'pmid': '25195661', 'type': 'BACKGROUND', 'citation': 'Ramamoorthi S, Nivedhitha MS, Divyanand MJ. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial. Aust Endod J. 2015 Aug;41(2):78-87. doi: 10.1111/aej.12076. Epub 2014 Sep 4.'}, {'pmid': '33624186', 'type': 'BACKGROUND', 'citation': 'Swimberghe RCD, Buyse R, Meire MA, De Moor RJG. Efficacy of different irrigation technique in simulated curved root canals. Lasers Med Sci. 2021 Aug;36(6):1317-1322. doi: 10.1007/s10103-021-03263-8. Epub 2021 Feb 23.'}, {'pmid': '19801244', 'type': 'BACKGROUND', 'citation': 'Brito PR, Souza LC, Machado de Oliveira JC, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. J Endod. 2009 Oct;35(10):1422-7. doi: 10.1016/j.joen.2009.07.001.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.', 'detailedDescription': 'Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.\n\nMethodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P \\< 0.05 considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-60 patient's age\n* Being systemically healthy\n* Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)\n\nExclusion Criteria:\n\n* Clinically symptomatic teeth\n* Patients with complicated systemic disease (ASA 3 - 6)\n* Teeth with open apex\n* Teeth having curvature more than 20 degree\n* Not having enough tooth structure to be isolated with rubber dam\n* Patients with severe periodontal defects or deep periodontal pockets (probing depth\\> 4 mm)\n* A history of taking analgesics 12 hours ago or antibiotics 1 month ago\n* Patients who cannot come to control sessions"}, 'identificationModule': {'nctId': 'NCT06339905', 'briefTitle': 'The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success', 'orgStudyIdInfo': {'id': '10840098-772.02-5564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sonic Activation with EndoActivator', 'description': 'Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm.', 'interventionNames': ['Procedure: Sonic Activation with EndoActivator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional needle irrigation (control)', 'description': 'Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute.', 'interventionNames': ['Procedure: Control Needle Irrigation']}], 'interventions': [{'name': 'Sonic Activation with EndoActivator', 'type': 'PROCEDURE', 'otherNames': ['EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA)'], 'description': 'sonic activation', 'armGroupLabels': ['Sonic Activation with EndoActivator']}, {'name': 'Control Needle Irrigation', 'type': 'PROCEDURE', 'otherNames': ['CNI'], 'description': 'control group', 'armGroupLabels': ['Conventional needle irrigation (control)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Esenler', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University, Faculty of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Seyda Ersahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Medipol University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After its publication in a journal, the investigators want to share their data.', 'ipdSharing': 'YES', 'description': 'After its publication in a journal, the investigators want to share their data.', 'accessCriteria': 'Postoperative pain scores, radiographic and clinical findings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research', 'investigatorFullName': 'yeldaerdem', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}