Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 8:28 AM
Study NCT ID:
NCT03745105
Status:
UNKNOWN
Last Update Posted:
2018-11-23
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D008619', 'term': 'Mepivacaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain assessed with the Numerical Rating Pain Scale', 'timeFrame': 'up to 48 hours after root canal treatment (At 4,6,12,24 and 48 hours after root canal treatment ).', 'description': 'Intensity of pain after endodontic treatment is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )'}], 'secondaryOutcomes': [{'measure': 'number of analgesics taken by the patient', 'timeFrame': 'Until 48 hours after endodontic treatment.', 'description': 'Number of analgesic tablets taken by the patient after endodontic treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '27790253', 'type': 'BACKGROUND', 'citation': 'Mehrvarzfar P, Esnashari E, Salmanzadeh R, Fazlyab M, Fazlyab M. Effect of Dexamethasone Intraligamentary Injection on Post-Endodontic Pain in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial. Iran Endod J. 2016 Fall;11(4):261-266. doi: 10.22037/iej.2016.2.'}, {'pmid': '22432824', 'type': 'BACKGROUND', 'citation': 'Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'the study is conducted to assess and compare the efficacy of local intraligamentary injection of glucocorticoids(dexamethasone) and NSAID(piroxicam) on reduction of postoperative pain in patients with symptomatic irreversible pulpitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systemically healthy patient (ASA I or II).\n2. Mandibular Posterior teeth with:\n\n * Preoperative sharp pain.\n * Absence of widening in the periodontal ligament (PDL).\n * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).\n\nExclusion Criteria:\n\n1. Patients allergic to anesthetics, piroxicam (any other NSAIDs) or dexamethasone (other corticosteroids).\n2. Pregnant or nursing females.\n3. Patients having significant systemic disorder (ASA III or IV).\n4. Hemostatic disorders or anti-coagulant therapy during the last month.\n5. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 hrs before treatment.\n6. Retreatment cases.'}, 'identificationModule': {'nctId': 'NCT03745105', 'briefTitle': 'Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexamethasone', 'description': 'Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt)', 'interventionNames': ['Drug: Dexamethasone sodium phosphate']}, {'type': 'EXPERIMENTAL', 'label': 'piroxicam', 'description': 'Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)', 'interventionNames': ['Drug: Piroxicam Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepivacaine HCL', 'description': 'Pretreatment Intraligamentary injection of 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml (Mepecaine - L, Alexandria Co.-Egypt)', 'interventionNames': ['Drug: Mepivacaine HCL']}], 'interventions': [{'name': 'Dexamethasone sodium phosphate', 'type': 'DRUG', 'description': 'prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.', 'armGroupLabels': ['dexamethasone']}, {'name': 'Piroxicam Injectable Solution', 'type': 'DRUG', 'description': 'prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam', 'armGroupLabels': ['piroxicam']}, {'name': 'Mepivacaine HCL', 'type': 'DRUG', 'description': 'prophylactic intraligamentary supplemental injection 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml', 'armGroupLabels': ['Mepivacaine HCL']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Safwa Es. Abd Elglil, B.D.S. (Cairo University)', 'role': 'CONTACT', 'email': 'safwaessam91@gmail.com', 'phone': '01001259618', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at faculty of dentistry cairo university', 'investigatorFullName': 'Safwa Essam Mohammed Ahmed Abd el-glil', 'investigatorAffiliation': 'Cairo University'}}}}