Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-05 @ 11:41 PM
Study NCT ID:
NCT03341260
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2017-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be randomly divided into 2 groups:\n\nExperimental group:\n\n50 mg Diclofenac Potassium to be administered one hour before treatment.\n\nControl group:\n\nPlacebo to be administered one hour before treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-06', 'studyFirstSubmitDate': '2017-11-05', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative endodontic pain', 'timeFrame': 'Up to 2 days after endodontic treatment', 'description': 'Pain after completion root canal treatment measured by Heft-parker visual analogue scale.'}], 'secondaryOutcomes': [{'measure': 'Analgesic intake', 'timeFrame': 'Up to 2 days after endodontic treatment', 'description': 'The incidence of analgesic intake is recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpitis, irreversible Pulpitis,', 'Diclofenac Potassium', 'Premedication, Preoperative Analgesic', 'Postoperative pain'], 'conditions': ['Pulpitis - Irreversible']}, 'referencesModule': {'references': [{'pmid': '27080115', 'type': 'BACKGROUND', 'citation': 'Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.'}, {'pmid': '26957785', 'type': 'BACKGROUND', 'citation': 'Metri M, Hegde S, Bhandi S. Effect of pretreatment diclofenac sodium on postendodontic pain: A randomised controlled trial. J Conserv Dent. 2016 Jan-Feb;19(1):7-10. doi: 10.4103/0972-0707.173183.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.', 'detailedDescription': 'Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with active pain (moderate-to-severe) in mandibular molars.\n* Patients with prolonged response to cold testing and electric pulp tester.\n* Patient with the ability to understand and use pain scales.\n* Patient with vital coronal pulp tissue on access.\n* Patient who accept to enroll to the study.\n\nExclusion Criteria:\n\n* Patients' allergies or any other contraindication to diclofenac potassium or articaine.\n* Pregnant and lactating females.\n* Patients having pain medication in the last 6 hours.\n* Patient has more than one symptomatic mandibular tooth in the same quadrant.\n* Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.\n* Patients with active peptic ulcer and gastrointestinal disorders.\n* Patients with history of bleeding problems or anticoagulant use within the last month."}, 'identificationModule': {'nctId': 'NCT03341260', 'briefTitle': 'Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Preoperative, Single-dose Diclofenac Potassium on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEBC-CU-2016-11-167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Potassium 50mg tab', 'description': 'Diclofenac Potassium 50mg tablet to be administered one hour before treatment.', 'interventionNames': ['Drug: Diclofenac Potassium 50mg Tab.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to be administered one hour before treatment.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diclofenac Potassium 50mg Tab.', 'type': 'DRUG', 'description': 'A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.', 'armGroupLabels': ['Diclofenac Potassium 50mg tab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A placebo will be taken one hour before initiation of endodontic treatment.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dentistry Faculty', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amatallah H Al-Rawhani, Pos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Oral and Dental Medicine/ Cairo University.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Student in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University.', 'investigatorFullName': 'Amatallah Hussein Nasser Al-Rawhani', 'investigatorAffiliation': 'Cairo University'}}}}