Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-29 @ 1:27 AM
Study NCT ID:
NCT06518304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-21
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of GentleWave System in Endodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D019553', 'term': 'Tooth, Nonvital'}], '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': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate whether using the Gentlewave system demonstrates a significant reduction in the level of postoperative pain after endodontic treatment measured by the VAS (Visual Analog Scale).', 'timeFrame': '24 hours', 'description': 'Pain measurements were made using a VAS (Visual Analog Scale of 0-10. Where the value of 0 represented absence of pain and value 10 represented the greatest intensity of pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Root Canal Infection', 'Endodontically Treated Teeth']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of the GentleWave® System compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment.', 'detailedDescription': 'New irrigation modalities such as the GentleWave® System, which integrates advanced multisonic ultrasound technology, have been developed to overcome limitations and improve root canal treatments success rates, by ensuring comprehensive cleaning while minimizing mechanical instrumentation. This system, featuring CleanFlow technology, optimizes the delivery of irrigants and promotes efficient root canal debridement. Postoperative pain is common, usually peaking within the first 24 hours after treatment and decreasing thereafter.\n\nIn the presence of necrosis, microorganisms can colonize anatomical complexities, such as isthmuses, ramifications and dentinal tubules causing symptoms such as pain, inflammation, and in some cases even odontogenic sinusitis. Conventional Syringe Irrigation (CSI), which delivers irrigants (NaOCl, EDTA) through a needle-syringe system, often fails to reach the entire working length and the intricate anatomy of the root canal. This inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure; furthermore, positive pressure exerted during CSI may cause the extrusion of irrigants beyond the apex, leading to complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients from 18 years age or older (maximum of 80 years of age), both genders.\n* The patients in need of an endodontic intervention.\n* All dental groups in both arches were eligible.\n* Patients who do or do not experience symptoms after the endodontic intervention.\n* Patient-signed informed consent/assent form\n\nExclusion Criteria:\n\n* Patients\\< 18 years old.\n* fractured teeth.\n* Patients who were recommended extraction after the endodontic evaluation.'}, 'identificationModule': {'nctId': 'NCT06518304', 'briefTitle': 'Effectiveness of GentleWave System in Endodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'Randomized Controlled Trial: Effectiveness of GentleWave System in Endodontic Treatment and Its Impact on Reducing Post- Operative Pain.', 'orgStudyIdInfo': {'id': 'U1111-1310-8953'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GentleWave', 'description': 'Featuring a handpiece CleanFlow technology, optimizes the delivery of irrigants: initially, a 3% NaOCl solution for 3 or 5 minutes, followed by a water rinse for 15 or 30 seconds, an 8% EDTA solution for 2 minutes, and a final distilled water rinse for 15 or 30 seconds. These solutions penetrate and eliminate necrotic tissue, debris, biofilm and bacteria, leaving the dentin intact and preserving the tooth structure. Use of the Gentlewave system is contraindicated in teeth with immature apices, teeth with insufficient coronal structure, and teeth with root apices that extend into the maxillary sinus.', 'interventionNames': ['Other: GentleWave']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Conventional Syringe Irrigation (CSI), which delivers irrigants (NaOCl, EDTA) through a needle-syringe system. After local anesthesia, the tooth will be isolated with a rubber dam. The pulp chamber will be accessed using ultrasound, eliminating all cavities, restorations with microfiltration or creating access through metal crowns. All canals will be cleaned and shaped with rotary files until at least a canal size of 20.6 or 25.04 is achieved within 0.5 to 1 mm of the apical end. Between each file, 6% NaOCl will be used to disinfect and clean the waste channels. Each canal will then be soaked in 17% EDTA for 1 minute, rinsed with 6% NaOCl, and finally subjected to a final saline rinse. The canals will be filled with root canal sealant and gutta-percha.', 'interventionNames': ['Other: Conventional Protocol']}], 'interventions': [{'name': 'GentleWave', 'type': 'OTHER', 'description': 'GentleWave System employs a degassing process that removes dissolved gases from the solution. This optimization prevents the vapor-lock effect and ensures effective energy transmission through the root canal. As the solution enters the pulp chamber, hydrodynamic cavitation occurs, creating microbubbles that implode and generate sound waves across a broad frequency spectrum', 'armGroupLabels': ['GentleWave']}, {'name': 'Conventional Protocol', 'type': 'OTHER', 'description': 'Delivers irrigants (NaOCl, EDTA) through a needle-syringe system, often fails to reach the entire working length. This inadequacy can result in residual bacteria and necrotic tissue, potentially compromising treatment efficacy and increasing the risk of treatment failure.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'Manhattan', 'state': 'New York', 'country': 'United States', 'facility': 'City Endodontics', 'geoPoint': {'lat': 40.78343, 'lon': -73.96625}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Author- Principal Investigator', 'investigatorFullName': 'Heilyn Nils', 'investigatorAffiliation': 'University of Salamanca'}}}}