Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 2:52 PM
Study NCT ID:
NCT05722704
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Cryotherapy on Post-endodontic Pain
Sponsor:
Organization:
Raw JSON
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The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)"}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.424', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.05', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': "Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cryotherapy', 'description': 'Final irrigation with cold saline (2.5C-4C) without occlusal reduction\n\nCryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction'}, {'id': 'FG001', 'title': 'Occlusal Reduction', 'description': 'Normal room temperature saline irrigation protocol with occlusal reduction\n\nOcclusal reduction: Reduction of the functional and non-functional cusps'}, {'id': 'FG002', 'title': 'Control', 'description': 'Normal room temperature saline irrigation protocol without occlusal reduction'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cryotherapy', 'description': 'Final irrigation with cold saline (2.5C-4C) without occlusal reduction\n\nCryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction'}, {'id': 'BG001', 'title': 'Occlusal Reduction', 'description': 'Normal room temperature saline irrigation protocol with 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[{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Arab Emirates', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-13', 'size': 434519, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2024-11-13T03:46', 'hasProtocol': True}, {'date': '2024-11-13', 'size': 42203, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-13T03:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2023-01-23', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-13', 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Level of Post-endodontic Pain', 'timeFrame': '6 hours', 'description': "Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)"}, {'measure': 'The Level of Post-endodontic Pain', 'timeFrame': '24 hours', 'description': "Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)"}, {'measure': 'The Level of Post-endodontic Pain', 'timeFrame': '48 hours', 'description': "Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)"}, {'measure': 'The Level of Post-endodontic Pain', 'timeFrame': '72 hours', 'description': "Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post endodontic pain', 'Cryotherapy', 'Occlusal reduction', 'Root canal treatment'], 'conditions': ['Cryotherapy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is:\n\nIs there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars?\n\nParticipants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction.\n\nResearchers will compare \\[Cryotherapy, occlusal reduction, and no intervention\\] to see the intensity of post-endodontic pain.', 'detailedDescription': 'The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the operator and the patients will not be aware of their group/used root canal irrigant.\n\nGroup I : normal room temperature saline irrigation protocol without occlusal reduction.\n\nGroup II : normal room temperature saline irrigation protocol with occlusal reduction.\n\nGroup III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.\n\nProcedural steps:\n\n1. Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.\n2. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.\n3. Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.\n4. After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.\n5. Hand instrumentation to 15-size K files.\n6. All the canals will be prepared using ProTaper Gold rotary files till the master apical file F2.\n7. Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.\n8. All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.\n9. In group I the root canals will be obturated directly after preparation.\n10. In group II occlusal reduction will be performed after root canal preparation.\n11. For group III the root canals will be irrigated for 5 min using 20 ml cryo-treated saline maintained at a temperature of 2°C-4°C.\n12. After completion of cleaning and shaping dried using appropriate size paper points and the canals will be obturated using gutta-percha, and restored by permanent composite restoration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-70 years\n2. A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis\n3. require endodontic therapy\n4. Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis\n5. Healthy patients without systemic disease\n6. Permanent mature first mandibular molars\n\nExclusion Criteria:\n\n1. Medically compromised patients\n2. Pregnant patients\n3. Teeth with incomplete apex formation\n4. Teeth with calcified canals\n5. Periapical abscess\n6. Patients on antibiotic therapy'}, 'identificationModule': {'nctId': 'NCT05722704', 'briefTitle': 'Effect of Cryotherapy on Post-endodontic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Gulf Medical University'}, 'officialTitle': 'Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients With Symptomatic Apical Periodontitis', 'orgStudyIdInfo': {'id': 'IRB/COD/STD/14/May-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryotherapy', 'description': 'Final irrigation with cold saline (2.5C-4C) without occlusal reduction', 'interventionNames': ['Procedure: Cryotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Occlusal reduction', 'description': 'Normal room temperature saline irrigation protocol with occlusal reduction', 'interventionNames': ['Procedure: Occlusal reduction']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Normal room temperature saline irrigation protocol without occlusal reduction'}], 'interventions': [{'name': 'Cryotherapy', 'type': 'PROCEDURE', 'description': 'Final irrigation with cold saline (2.5C-4C) without occlusal reduction', 'armGroupLabels': ['Cryotherapy']}, {'name': 'Occlusal reduction', 'type': 'PROCEDURE', 'description': 'Reduction of the functional and non-functional cusps', 'armGroupLabels': ['Occlusal reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4184', 'city': 'Ajman', 'country': 'United Arab Emirates', 'facility': 'Gulf Medical University', 'geoPoint': {'lat': 25.40177, 'lon': 55.47878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulf Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Cell Biology and Researcher', 'investigatorFullName': 'Rania Zaarour', 'investigatorAffiliation': 'Gulf Medical University'}}}}