Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-01 @ 4:37 PM
Study NCT ID:
NCT04552132
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2020-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'davidbingham1623@gmail.com', 'phone': '208-851-0618', 'title': 'Dr. David Bingham', 'organization': 'Saint Louis University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 10 months.', 'eventGroups': [{'id': 'EG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.75', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '16.23', 'spread': '27.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 09/2020-06/2021 that completed and returned their paperwork.'}, {'type': 'PRIMARY', 'title': '24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.86', 'spread': '18.65', 'groupId': 'OG000'}, {'value': '17.00', 'spread': '18.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hr postoperatively', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 07/2021-03/2022 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': '48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.58', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '11.73', 'spread': '19.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '48 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 09/2020-06/2021 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': '48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.86', 'spread': '12.35', 'groupId': 'OG000'}, {'value': '10.07', 'spread': '11.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '48 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 07/2021-03/2022 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': '72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.46', 'spread': '14.36', 'groupId': 'OG000'}, {'value': '7.30', 'spread': '13.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '72 hour post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 09/2020-06/2021 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': '72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.57', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '5.86', 'spread': '10.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '72 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 07/2021-03/2022 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': '96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.96', 'spread': '19.98', 'groupId': 'OG000'}, {'value': '7.53', 'spread': '16.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '96 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 09/2020-06/2021 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': '96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.57', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '3.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '96 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 07/2021-03/2022 that completed and returned their paperwork'}, {'type': 'PRIMARY', 'title': 'Cone Beam Computed Tomography (CBCT) Healing Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'units': 'Roots (teeth have multiple roots)', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'title': 'Healed', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Healing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Diseased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 month recall', 'description': 'Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op.', 'unitOfMeasure': 'roots', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Roots (teeth have multiple roots)', 'denomUnitsSelected': 'Roots (teeth have multiple roots)', 'populationDescription': 'Patients that were able to return for a 12-month recall before the study ended.'}, {'type': 'PRIMARY', 'title': 'Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'units': 'Teeth', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.4993', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12-month recall', 'description': 'Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters.', 'unitOfMeasure': 'teeth', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Teeth', 'denomUnitsSelected': 'Teeth', 'populationDescription': 'Patients that could return for a 12-month recall before study ended.'}, {'type': 'SECONDARY', 'title': 'Pain Pill Consumption for Patients Seen From 09/2021-06/2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.08', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '6.63', 'spread': '7.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.', 'description': 'Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient.', 'unitOfMeasure': 'pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 09/2020-06/2021 that completed and returned their paperwork'}, {'type': 'SECONDARY', 'title': 'Pain Pill Consumption for Patients Seen From 07/2021-03/2022', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'OG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '8.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.70', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.', 'description': 'Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient.', 'unitOfMeasure': 'pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants seen from 07/2021-03/2022 that completed and returned their paperwork'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'FG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After enrollment, no patients were excluded from the study prior to assignment of group. However, the data for one participant in the GentleWave group was excluded from final data analysis because it was determined that their preoperative pain was insufficient for the study and they should not have been enrolled in the first place.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'BG001', 'title': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.\n\nMultisonic vs Sonic activation of irrigants: Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.33', 'spread': '14.40', 'groupId': 'BG000'}, {'value': '43.44', 'spread': '11.98', 'groupId': 'BG001'}, {'value': '43.87', 'spread': '13.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-operative pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.00', 'spread': '24.67', 'groupId': 'BG000'}, {'value': '70.80', 'spread': '23.45', 'groupId': 'BG001'}, {'value': '68.50', 'spread': '24.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-02', 'size': 183931, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-07T18:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-20', 'studyFirstSubmitDate': '2020-09-13', 'resultsFirstSubmitDate': '2023-02-25', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-20', 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'timeFrame': '24 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'timeFrame': '24 hr postoperatively', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'timeFrame': '48 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'timeFrame': '48 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'timeFrame': '72 hour post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'timeFrame': '72 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021', 'timeFrame': '96 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': '96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022', 'timeFrame': '96 hours post-operative', 'description': "Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100)."}, {'measure': 'Cone Beam Computed Tomography (CBCT) Healing Assessment', 'timeFrame': '12 month recall', 'description': 'Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op.'}, {'measure': 'Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report', 'timeFrame': '12-month recall', 'description': 'Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters.'}], 'secondaryOutcomes': [{'measure': 'Pain Pill Consumption for Patients Seen From 09/2021-06/2021', 'timeFrame': 'Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.', 'description': 'Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient.'}, {'measure': 'Pain Pill Consumption for Patients Seen From 07/2021-03/2022', 'timeFrame': 'Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.', 'description': 'Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Symptomatic Irreversible Pulpitis', 'Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'Patients with painful molars will be randomly assigned to 2 different groups: GentleWave and EndoActivator. The root canals will be completed using identical protocols except in the mode of delivery and activation of irrigation (using either the GentleWave or EndoActivator). Postoperative pain and pain pill consumption will be measured for the 4 days following their root canal using a Visual Analog Scale and Pain Pill Log, respectively. The alternative hypothesis is that patients undergoing treatment using the GentleWave will experience less pain postoperatively and will consume fewer pain pills.\n\nA 12-month follow up with exam and radiographs will be completed to evaluate healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Adults, able to provide informed consent, with restorable symptomatic molars reporting preoperative pain ≥20mm on a 100mm Visual Analog Scale (VAS) during the previous 24 hours.\n\nExclusion Criteria:\n\n* Minors\n* Pregnant women\n* Prisoners\n* Persons unable to adequately provide informed consent\n* Non-restorable teeth\n* Patients unable to sit in the dental chair for 3 hours\n* Patients with compromised cardiac health requiring less than .08mg epinephrine\n* Patients with a pacemaker\n* Patients where Ibuprofen and Acetaminophen are contraindicated\n* Patients unable to swallow pills\n* Patients with pain originating somewhere other than the tooth in question\n* Patients having taken analgesics within previous 6 hours'}, 'identificationModule': {'nctId': 'NCT04552132', 'briefTitle': 'Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'Postoperative Pain and Healing of Molar Root Canal Teeth Using GentleWave vs. EndoActivator', 'orgStudyIdInfo': {'id': '31359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GentleWave', 'description': 'Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.', 'interventionNames': ['Device: Multisonic vs Sonic activation of irrigants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EndoActivator', 'description': 'Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.', 'interventionNames': ['Device: Multisonic vs Sonic activation of irrigants']}], 'interventions': [{'name': 'Multisonic vs Sonic activation of irrigants', 'type': 'DEVICE', 'description': 'Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.', 'armGroupLabels': ['EndoActivator', 'GentleWave']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Center for Advanced Dental Education', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'David Bingham, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident at the Center for Advanced Dental Education'}, {'name': 'Brian Judd, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident at the Center for Advanced Dental Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Endodontic Resident at the Center for Advanced Dental Education', 'investigatorFullName': 'David Bingham, DDS', 'investigatorAffiliation': 'St. Louis University'}}}}