Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 6:20 PM
Study NCT ID:
NCT04593160
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anesthetic success of inferior alveolar nerve block', 'timeFrame': 'During the treatment', 'description': 'Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain at 6 hours', 'timeFrame': '6 hours', 'description': 'Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"'}, {'measure': 'Postoperative pain at 12 hours', 'timeFrame': '12 hours', 'description': 'Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"'}, {'measure': 'Postoperative pain at 24 hours', 'timeFrame': '24 hours', 'description': 'represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"'}, {'measure': 'Postoperative pain at 48 hours', 'timeFrame': '48 hours', 'description': 'represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"'}, {'measure': 'Postoperative pain at 72 hours', 'timeFrame': '72 hours', 'description': 'represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"'}, {'measure': 'Postoperative pain at 7 days', 'timeFrame': '7 days', 'description': 'represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Symptomatic Irreversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '29709297', 'type': 'BACKGROUND', 'citation': 'Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.'}, {'pmid': '17185119', 'type': 'BACKGROUND', 'citation': 'Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.'}, {'pmid': '32470370', 'type': 'BACKGROUND', 'citation': 'Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.', 'detailedDescription': 'Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic irreversible pulpitis with/without mechanical allodynia\n* Patients with moderato to severe spontaneous pain\n* Mandibular molars\n* Patients with the ability to understand and use the pain scale\n* Patients accepting enrollment in the study\n\nExclusion Criteria:\n\n* Patients allergic to any medication or material to be used in the study\n* Pregnant and lactating females\n* Patients taking medications affecting pain perception in the last 12 hours\n* Patients having more than one symptomatic molar in the same quadrant\n* Patients with contributory medical history (ASA \\> II)'}, 'identificationModule': {'nctId': 'NCT04593160', 'briefTitle': 'Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CU-ENDO-6-10-2020.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac potassium- acetaminophen combination', 'description': 'Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination', 'interventionNames': ['Drug: Diclofenac potassium- acetaminophen combination']}, {'type': 'EXPERIMENTAL', 'label': 'Diclofenac potassium', 'description': 'Preoperative single dose of diclofenac potassium(50mg)', 'interventionNames': ['Drug: Diclofenac potassium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Preoperative single dose of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diclofenac potassium- acetaminophen combination', 'type': 'DRUG', 'description': 'Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination', 'armGroupLabels': ['Diclofenac potassium- acetaminophen combination']}, {'name': 'Diclofenac potassium', 'type': 'DRUG', 'description': 'Preoperative single dose of diclofenac potassium(50mg)', 'armGroupLabels': ['Diclofenac potassium']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Preoperative single dose of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sovana T. Abd El-Monem', 'role': 'CONTACT', 'email': 'sovana.tarek241@gmail.com', 'phone': '+201005173697'}, {'name': 'Suzan Amin', 'role': 'CONTACT', 'email': 'suzan.wanis@dentistry.cu.edu.eg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate student', 'investigatorFullName': 'Sovana Tarek', 'investigatorAffiliation': 'Cairo University'}}}}