Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT03716635
Status:
UNKNOWN
Last Update Posted:
2018-10-24
First Post:
2018-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cryotherapy on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'After determining the eligibility of the patient, the assistant supervisor will be contacted to assign the participant to either the intervention (cryotherapy) or the control (normal saline) groups according to the random sequence generated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A random sequence will be generated by computer software, (http://www.random.org/).\n\nThe table will be kept with the assistant supervisor.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-10-20', 'studyFirstSubmitQcDate': '2018-10-20', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain assessed by NRS', 'timeFrame': 'up to 48 hrs postoperative pain', 'description': 'Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain"\n\n1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"'}], 'secondaryOutcomes': [{'measure': 'amount of analgesics assessed by counting', 'timeFrame': 'up to 48 hrs postoperatively', 'description': 'number of analgesics tablets up to 48 hrs postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Symptomatic Irreversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '29398090', 'type': 'BACKGROUND', 'citation': 'Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis', 'detailedDescription': 'the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-40 years old.\n* Systemically healthy patient (ASA I or II).\n* mandibular first molar teeth with:\n* Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).\n* Ability for isolation with rubberdam.\n* Restorable teeth\n* Ability to fill the root canals in single visit treatment.\n\nExclusion Criteria:\n\n* Teeth without good apical constriction, such as wide or open apex\n* Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.\n* Patients having significant systemic disorder (ASA III or IV).\n* Teeth that have :\n\nNon vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability'}, 'identificationModule': {'nctId': 'NCT03716635', 'briefTitle': 'Effect of Cryotherapy on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-10-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cryotherapy', 'description': '2.5c cold saline as a final flush after chemicomechanical debridement', 'interventionNames': ['Procedure: cryotherapy']}, {'type': 'OTHER', 'label': 'normal saline', 'description': 'room temperature saline is used as a final flush after chemicomechanical preparation', 'interventionNames': ['Procedure: normal saline']}], 'interventions': [{'name': 'cryotherapy', 'type': 'PROCEDURE', 'description': '2.5c cold saline is used as a final flush after chemomechanical preparation', 'armGroupLabels': ['cryotherapy']}, {'name': 'normal saline', 'type': 'PROCEDURE', 'description': 'a room temperature saline is used as a final flush after mechanical preparation', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'magy E elaskary', 'role': 'CONTACT', 'email': 'magiessam@gmail.com', 'phone': '01001467262'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at endodontic department cairo university', 'investigatorFullName': 'Magy Essam Sayed El-Askary', 'investigatorAffiliation': 'Cairo University'}}}}