Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02285595
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2014-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy
Sponsor:
Organization:
Raw JSON
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Score of 1: Normal. Score of 2: Small changes in bone structure. Score of 3: Changes in bone structure with some mineral loss (bone loss). Score of 4: Periodontitis with well-defined radiolucent area (apical periodontitis). Score of 5: Severe Periodontitis with exacerbating features (apical periodontitis).\n\nHealed is defined by absence of a radiographic indication of apical periodontitis (PAI \\<3) and absence of clinical signs and symptoms other than tenderness to percussion.\n\nHealing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Periradicular Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave™ Treatment Group', 'description': 'Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.'}], 'classes': [{'categories': [{'title': 'Normal Apical Tissue', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Symptomatic Apical Periodontitis', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Asymptomatic Apical Periodontitis', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Acute Apical Abscess', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Chronic Apical Abscess', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Condensing Osteitis', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Healing Within Normal Limits', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Symptomatic Apical Periodontitis: Inflammation, with clinical symptoms. 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Healed is defined by absence of a radiographic indication of apical periodontitis (PAI \\<3) and absence of clinical signs and symptoms other than tenderness to percussion.\n\nHealing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GentleWave™ Treatment Group', 'description': 'Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GentleWave™ Treatment Group', 'description': 'Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Black/ African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Caucasian', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PAI Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'PAI Score < 3', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'PAI Score = 3', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'PAI Score 4 or 5', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Orstavik D., Kerekes K, Ericksen H. M. The periapical index: A scoring system for radiographic assessment of apical periodontitis. Dent Traumatol J 1986;2: 20-34.\n\nScore of 1: Normal Score of 2: Small changes in bone structure Score of 3: Changes in bone structure with some mineral loss (bone loss) Score of 4: Periodontitis with well-defined radiolucent area (apical periodontitis) Score of 5: Severe Periodontitis with exacerbating features (apical periodontitis)', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject had withdrawn from the study prior to data analysis. Healed is defined by absence of a radiographic indication of apical peridontitis (PAI \\<3) and absence of clinical signs and symptoms other than tenderness to percussion.'}, {'title': 'Periradicular Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Normal periradicular tissue', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Healing within normal limits', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Symptomatic apical periodontitis', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Asymptomatic apical periodontitis', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Acute Apical Abscess', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Chronic Apical Abscess', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Condensing Osteitis', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'AAE Consensus Conference Recommended Diagnostic Terminology, JOE 35(12):1634, 2009.\n\nSymptomatic Apical Periodontitis: Inflammation, with clinical symptoms. Asymptomatic Apical Periodontitis: Inflammation with apical radiolucent area, does not produce clinical symptoms.\n\nAcute Apical Abscess: Inflammation characterized by rapid onset of clinical symptoms and swelling.\n\nChronic Apical Abscess: Inflammation characterized by gradual onset, little or no discomfort, presence of a sinus tract.\n\nCondensing Osteitis: Diffuse radiopaque lesion representing a localized bony reaction to inflammation.', 'unitOfMeasure': 'Participants', 'populationDescription': 'One patient withdrew prior to data analysis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-23', 'size': 1641113, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-22T13:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2014-11-03', 'resultsFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-05', 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5', 'timeFrame': '12 months', 'description': 'The periapical index: A scoring system for radiographic assessment of apical periodontitis. Score of 1: Normal. Score of 2: Small changes in bone structure. Score of 3: Changes in bone structure with some mineral loss (bone loss). Score of 4: Periodontitis with well-defined radiolucent area (apical periodontitis). Score of 5: Severe Periodontitis with exacerbating features (apical periodontitis).\n\nHealed is defined by absence of a radiographic indication of apical periodontitis (PAI \\<3) and absence of clinical signs and symptoms other than tenderness to percussion.\n\nHealing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.'}, {'measure': 'Periradicular Diagnosis', 'timeFrame': '12 months', 'description': 'Symptomatic Apical Periodontitis: Inflammation, with clinical symptoms. Asymptomatic Apical Periodontitis: Inflammation with apical radiolucent area, does not produce clinical symptoms. Acute Apical Abscess: Inflammation characterized by rapid onset of clinical symptoms and swelling. Chronic Apical Abscess: Inflammation characterized by gradual onset, little or no discomfort, presence of a sinus tract. Condensing Osteitis: Diffuse radiopaque lesion representing a localized bony reaction to inflammation. Healed is defined by absence of a radiographic indication of apical periodontitis (PAI \\<3) and absence of clinical signs and symptoms other than tenderness to percussion.\n\nHealing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Root Canal Therapy']}, 'referencesModule': {'references': [{'pmid': '12193268', 'type': 'BACKGROUND', 'citation': 'Peters OA, Schonenberger K, Laib A. Effects of four Ni-Ti preparation techniques on root canal geometry assessed by micro computed tomography. Int Endod J. 2001 Apr;34(3):221-30. doi: 10.1046/j.1365-2591.2001.00373.x.'}, {'pmid': '12657151', 'type': 'BACKGROUND', 'citation': 'Peters OA, Peters CI, Schonenberger K, Barbakow F. ProTaper rotary root canal preparation: effects of canal anatomy on final shape analysed by micro CT. Int Endod J. 2003 Feb;36(2):86-92. doi: 10.1046/j.1365-2591.2003.00626.x.'}, {'pmid': '11471648', 'type': 'BACKGROUND', 'citation': 'Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022.'}, {'pmid': '15851929', 'type': 'BACKGROUND', 'citation': 'McGurkin-Smith R, Trope M, Caplan D, Sigurdsson A. Reduction of intracanal bacteria using GT rotary instrumentation, 5.25% NaOCl, EDTA, and Ca(OH)2. J Endod. 2005 May;31(5):359-63. doi: 10.1097/01.don.0000145035.85272.7c.'}, {'pmid': '11601772', 'type': 'BACKGROUND', 'citation': 'Hulsmann M, Schade M, Schafers F. A comparative study of root canal preparation with HERO 642 and Quantec SC rotary Ni-Ti instruments. Int Endod J. 2001 Oct;34(7):538-46. doi: 10.1046/j.1365-2591.2001.00431.x.'}, {'pmid': '19125977', 'type': 'BACKGROUND', 'citation': 'Vaudt J, Bitter K, Neumann K, Kielbassa AM. Ex vivo study on root canal instrumentation of two rotary nickel-titanium systems in comparison to stainless steel hand instruments. Int Endod J. 2009 Jan;42(1):22-33. doi: 10.1111/j.1365-2591.2008.01489.x.'}, {'pmid': '9587326', 'type': 'BACKGROUND', 'citation': 'Wilcox LR, Roskelley C, Sutton T. The relationship of root canal enlargement to finger-spreader induced vertical root fracture. 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No abstract available.'}, {'pmid': '1061800', 'type': 'BACKGROUND', 'citation': 'Vande Visse JE, Brilliant JD. Effect of irrigation on the production of extruded material at the root apex during instrumentation. J Endod. 1975 Jul;1(7):243-6. doi: 10.1016/s0099-2399(75)80227-5. No abstract available.'}, {'pmid': '6954443', 'type': 'BACKGROUND', 'citation': 'Martin H, Cunningham WT. The effect of endosonic and hand manipulation on the amount of root canal material extruded. Oral Surg Oral Med Oral Pathol. 1982 Jun;53(6):611-3. doi: 10.1016/0030-4220(82)90350-4. No abstract available.'}, {'pmid': '7561660', 'type': 'BACKGROUND', 'citation': 'al-Omari MA, Dummer PM. Canal blockage and debris extrusion with eight preparation techniques. J Endod. 1995 Mar;21(3):154-8. doi: 10.1016/s0099-2399(06)80443-7.'}, {'pmid': '9558583', 'type': 'BACKGROUND', 'citation': 'Reddy SA, Hicks ML. Apical extrusion of debris using two hand and two rotary instrumentation techniques. 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All patients will be followed for 24 months post procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 75 years of age\n* Indicated for root canal therapy\n* First or second molar\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Poor oral hygiene\n* Class II or III mobility\n* Open or incompletely formed root apices\n* Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)\n* Previous pulpectomy or root canal therapy\n\nNote: Additional exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02285595', 'acronym': 'SUPREME', 'briefTitle': 'Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonendo, Inc.'}, 'officialTitle': 'A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control', 'orgStudyIdInfo': {'id': 'CS-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sonendo GentleWave™ System', 'description': 'The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.', 'interventionNames': ['Device: Sonendo GentleWave™ System']}], 'interventions': [{'name': 'Sonendo GentleWave™ System', 'type': 'DEVICE', 'armGroupLabels': ['Sonendo GentleWave™ System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92656', 'city': 'Aliso Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Shahriar Rassoulian, DMD', 'geoPoint': {'lat': 33.56504, 'lon': -117.72712}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Khang Le, DDS', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Stacey Woo, DDS', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}], 'overallOfficials': [{'name': 'Dan Miller', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sonendo, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonendo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}