Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT03174860
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, '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\nDiclofenac Potassium (50 mg, Cataflam) 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': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of articaine buccal infiltration.', 'timeFrame': 'Intraoperative', 'description': 'Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.'}], 'secondaryOutcomes': [{'measure': 'Pain on injection', 'timeFrame': 'Intraoperative', 'description': 'The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpitis, irreversible Pulpitis, Hot tooth', 'Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic', 'Local anesthesia, Articaine, Buccal infiltration'], 'conditions': ['Pulpitis - Irreversible', 'Anesthesia, Local']}, 'referencesModule': {'references': [{'pmid': '24702239', 'type': 'BACKGROUND', 'citation': 'Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.'}, {'pmid': '21692235', 'type': 'BACKGROUND', 'citation': 'Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.', 'detailedDescription': 'This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.'}, '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': 'NCT03174860', 'briefTitle': 'Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEBC-CU-2016-11-167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Potassium 50mg tab', 'description': 'Diclofenac Potassium 50mg (Cataflam) 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', 'otherNames': ['Cataflam 50mg'], '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': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amatallah H Al-Rawhani, Postgraduate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Oral and Dental Medicine/ Cairo University.'}, {'name': 'Dr. Suzan AW Amin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Oral and Dental Medicine/ Cairo University.'}, {'name': "Shaima'a Gawdat, PhD", 'role': 'STUDY_DIRECTOR', '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'}}}}