Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT07106320
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Different Root Canal Irrigation Techniques
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-12', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post Operative Pain İntensity', 'timeFrame': 'From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment', 'description': 'The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Verbal Rating Scale (VRS), which categorizes pain into four levels: 0 (no pain), 1 (mild), 2 (moderate), and 3 (severe).'}], 'primaryOutcomes': [{'measure': 'Periapical Healing', 'timeFrame': 'From end of treatment to 1 year', 'description': 'The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Intensity - Visual Analog Scale', 'timeFrame': 'From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment', 'description': 'The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Visual Analog Scale (VAS) where 0 represents "no pain" and 10 represents "worst imaginable pain".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Irrigation activation', 'Sonic activation', 'Ultrasonic activation', 'Apical periodontitis', 'Periapical Healing', 'Post operative pain'], 'conditions': ['Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'This clinical study aims to evaluate the effect of different root canal irrigation techniques on postoperative pain levels and periapical healing in premolar and molar teeth diagnosed with apical periodontitis (Periapical Index (PAI) score 4-5). A total of 162 patients are randomly assigned to one of three groups: (1) sonic irrigation activation using EDDY, (2) ultrasonic irrigation activation using VDW Ultra, and (3) conventional syringe irrigation as the control. Postoperative pain will be recorded using the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) at multiple time points up to one month. Periapical healing will be assessed using periapical imaging performed with the parallel technique one year after treatment. The study aims to determine whether enhanced irrigation techniques provide superior clinical outcomes compared to traditional methods.', 'detailedDescription': 'Root canal treatment aims to eliminate microorganisms and their byproducts from the complex root canal system to allow periapical tissue healing. Due to the anatomical complexity of root canals-such as isthmuses, apical deltas, and lateral canals-mechanical preparation alone is often insufficient. Therefore, chemical irrigation plays a vital role in successful disinfection.\n\nThis randomized clinical trial investigates the influence of three different irrigation protocols on postoperative pain and periapical healing in permanent premolar and molar teeth with radiographically evident apical periodontitis (Periapical Index (PAI) score 4-5).\n\nThe study includes three experimental groups :\n\nGroup 1 (Sonic activation): Irrigation solution is activated using the EDDY sonic tip.\n\nGroup 2 (Ultrasonic activation): Irrigation is activated using VDW Ultra ultrasonic tips.\n\nGroup 3 (Control): Conventional needle irrigation is performed without activation.\n\nAll treatments will be performed under rubber dam isolation and local anesthesia, using a standardized instrumentation protocol with ProTaper Next rotary files. Between each file change, the root canal will be irrigated with 5 ml of 3% sodium hypochlorite (NaOCl). The final irrigation protocol will be applied according to the assigned group. All endodontic procedures will be completed in a single session.\n\nPostoperative pain levels will be assessed using both the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) scales at 6, 12, 18, 24, 48, and 72 hours, as well as on day 7 and at 1 month. Patients will be asked to record analgesic consumption (400 mg ibuprofen as needed) and will submit pain diaries.\n\nOne year after treatment, periapical healing will be evaluated using periapical radiography (parallel technique) by two blinded observers.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 60 years\n* Premolar and molar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis\n* Systemically healthy individuals\n* To be able to read and sign the informed consent form\n* Physical and mental fitness to undergo treatment\n* Willingness to attend all follow-up sessions\n\nExclusion Criteria:\n\n* Patients with systemic diseases classified as ASA III or higher\n* Presence of severe periodontal disease (probing depth \\>4 mm)\n* Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment'}, 'identificationModule': {'nctId': 'NCT07106320', 'briefTitle': 'Evaluation of Different Root Canal Irrigation Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Evaluation of the Effect of Different Root Canal Irrigation Techniques on Periapical Tissue Healing and Postoperative Pain in Teeth With Apical Periodontitis', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-6497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasonic Irrigation Activation (VDW Ultra)', 'description': 'Irrigation will be activated using an ultrasonic device (VDW Ultra) with an IRRI S tip positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated ultrasonically for 20seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions.', 'interventionNames': ['Device: VDW Ultra Ultrasonic Irrigation Activation']}, {'type': 'EXPERIMENTAL', 'label': 'Sonic Irrigation Activation (EDDY)', 'description': 'Irrigation will be activated using a sonic device (EDDY tip, VDW) positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated for 20 seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions.', 'interventionNames': ['Device: EDDY Sonic Irrigation Activation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Irrigation (Control)', 'description': 'Irrigation will be performed using a syringe and needle without activation. Final irrigation will be performed using conventional syringe and needle irrigation without any activation. Each canal will be irrigated with 6 mL of 3% Sodium Hypochlorite (NaOCl), followed by 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) and 5 mL of sterile saline, using a side-vented needle.', 'interventionNames': ['Procedure: Conventional Needle Irrigation']}], 'interventions': [{'name': 'VDW Ultra Ultrasonic Irrigation Activation', 'type': 'DEVICE', 'description': 'Irrigation will be activated using an ultrasonic tip (IRRI S 21/25) connected to the VDW Ultra device (VDW GmbH, Munich, Germany), 2 mm short of working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.', 'armGroupLabels': ['Ultrasonic Irrigation Activation (VDW Ultra)']}, {'name': 'EDDY Sonic Irrigation Activation', 'type': 'DEVICE', 'description': 'Irrigation solution will be activated using the EDDY sonic tip (VDW GmbH, Munich, Germany), positioned 2 mm short of the working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.', 'armGroupLabels': ['Sonic Irrigation Activation (EDDY)']}, {'name': 'Conventional Needle Irrigation', 'type': 'PROCEDURE', 'description': 'Irrigation will be performed using a syringe and needle without activation. A total of 6 ml NaOCl, 2 ml EDTA and 5 mL of sterile saline will be used during final irrigation.', 'armGroupLabels': ['Conventional 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}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared starting 6 months after publication.', 'ipdSharing': 'YES', 'description': 'All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication', 'accessCriteria': 'Qualified researchers may request access to all de-identified individual participant data (IPD) and study protocols. Access will be granted upon reasonable request by contacting the corresponding author via email and after signing a data sharing agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Endodontics, Medipol University', 'investigatorFullName': 'ASLI USTA TAHMAZ', 'investigatorAffiliation': 'Medipol University'}}}}