Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT05032612
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2021-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.c.kirkpatrick@uth.tmc.edu', 'phone': '713-486-4227', 'title': 'Timothy Kirkpatrick, DDS', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '72 hours', 'eventGroups': [{'id': 'EG000', 'title': 'PBM Therapy', 'description': 'PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PBM Sham', 'description': 'PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain as Assessed by the Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PBM Therapy', 'description': 'PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .'}, {'id': 'OG001', 'title': 'PBM Sham', 'description': 'PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '.33', 'spread': '.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours after treatment', 'description': 'This scale ranges form 0(no pain) to 10(worst pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain as Assessed by the Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PBM Therapy', 'description': 'PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .'}, {'id': 'OG001', 'title': 'PBM Sham', 'description': 'PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.'}], 'classes': [{'title': '0 hours after treatment', 'categories': [{'measurements': [{'value': '3.94', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': '6 hours after treatment', 'categories': [{'measurements': [{'value': '1.94', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': '12 hours after treatment', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '24 hours after treatment', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours, 6 hours, 12 hours and 24 hours hours after treatment', 'description': 'This scale ranges form 0(no pain) to 10(worst pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PBM Therapy', 'description': 'PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .'}, {'id': 'FG001', 'title': 'PBM Sham', 'description': 'PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PBM Therapy', 'description': 'PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .'}, {'id': 'BG001', 'title': 'PBM Sham', 'description': 'PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.05', 'spread': '12.83', 'groupId': 'BG000'}, {'value': '37.7', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', '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': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-14', 'size': 425760, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-01T13:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2021-08-26', 'resultsFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-01', 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as Assessed by the Visual Analog Scale', 'timeFrame': '72 hours after treatment', 'description': 'This scale ranges form 0(no pain) to 10(worst pain)'}], 'secondaryOutcomes': [{'measure': 'Pain as Assessed by the Visual Analog Scale', 'timeFrame': '0 hours, 6 hours, 12 hours and 24 hours hours after treatment', 'description': 'This scale ranges form 0(no pain) to 10(worst pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['endodontic treatment', 'mandibular molar teeth', 'apical periodontitis.'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of photobiomodulation (PBM) on postoperative pain after endodontic treatment in mandibular molar teeth diagnosed with symptomatic apical periodontitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Posterior mandibular molars\n* No previous root canal therapy on the tooth in question\n* Able to complete the endodontic treatment in one visit\n\nExclusion Criteria:\n\n* Maxillary teeth, mandibular anteriors and premolars\n* Infection (swelling, sinus tract) on the tooth in question\n* Periodontal disease on the tooth in question\n* Dental trauma\n* Crown/ root fractures\n* Systemic diseases\n* Immunocompromised patients'}, 'identificationModule': {'nctId': 'NCT05032612', 'briefTitle': 'Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis', 'orgStudyIdInfo': {'id': 'HSC-DB-21-0579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBM Therapy', 'interventionNames': ['Device: PBM Therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'PBM Sham', 'interventionNames': ['Device: PBM Sham']}], 'interventions': [{'name': 'PBM Therapy', 'type': 'DEVICE', 'description': 'After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .', 'armGroupLabels': ['PBM Therapy']}, {'name': 'PBM Sham', 'type': 'DEVICE', 'description': 'For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.', 'armGroupLabels': ['PBM Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ryne Jackson, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Timothy Kirkpatrick', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}