Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05660694
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2022-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Triamcinolone Group 2: Pentoxifylline'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper', 'timeFrame': '21 months', 'description': 'Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening'}, {'measure': 'Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper', 'timeFrame': '21 months', 'description': 'Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triamcinolone', 'Pentoxifylline', 'Vitamin E', 'Oral Submucosa Fibrosis', 'Tumor']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.', 'detailedDescription': 'To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.\n\nIt was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past\n* Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking\n* Patients who are ready to attend regular follow-ups\n\nExclusion Criteria:\n\n* Patients who have undergone any treatment for OSF in past\n* Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's\n* Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol"}, 'identificationModule': {'nctId': 'NCT05660694', 'briefTitle': 'Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Altamash Institute of Dental Medicine'}, 'officialTitle': 'Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial', 'orgStudyIdInfo': {'id': 'Treatment of OSF stage 2 and 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Triamcinolone', 'description': 'Injection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites', 'interventionNames': ['Drug: Triamcinolone']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Pentoxifylline with Vitamin E', 'description': 'Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks', 'interventionNames': ['Drug: Pentoxifylline with Vitamin E']}], 'interventions': [{'name': 'Triamcinolone', 'type': 'DRUG', 'description': 'Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy', 'armGroupLabels': ['Group 1: Triamcinolone']}, {'name': 'Pentoxifylline with Vitamin E', 'type': 'DRUG', 'description': 'Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy', 'armGroupLabels': ['Group 2: Pentoxifylline with Vitamin E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75500', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Altamash Institute of Dental Medicine', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altamash Institute of Dental Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Abhishek Lal', 'investigatorFullName': 'Abhishek Lal', 'investigatorAffiliation': 'Altamash Institute of Dental Medicine'}}}}