Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-30 @ 3:18 PM
Study NCT ID:
NCT01178203
Status:
COMPLETED
Last Update Posted:
2010-08-10
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'C106625', 'term': 'L 5409709'}, {'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-09', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endodontics', 'pain', 'visual analogue scale', 'NSAIDs'], 'conditions': ['Pulpitis', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'Aim: eliminating or reducing pain following endodontic treatment is of great importance. The aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis was evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subjects were 20-60 years of age with no systemic diseases and females were not pregnant;\n2. No history of taking any analgesics or other drugs prior to presenting for treatment;\n3. Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01178203', 'briefTitle': 'The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Azad University of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'IAU-1083'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo'}, {'name': 'Tramadol', 'type': 'DRUG', 'description': 'Tab, 100mg in 6, 12 and 24 hours after root canal treatment'}, {'name': 'Novafen', 'type': 'DRUG', 'description': '325 mg in 6, 12 and 24 hours after root canal treatment'}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Tab, 500 mg in 6, 12, and 24 hours after root canal treatment'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Peyman Mehrvarzfar', 'oldOrganization': 'Department of Endodontics, Dental School of Tehran Azad University of Medical Sciences'}}}}