Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-25 @ 1:12 AM
Study NCT ID:
NCT03771768
Status:
UNKNOWN
Last Update Posted:
2019-04-09
First Post:
2018-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D019226', 'term': 'Oral Ulcer'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'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': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "Double - blinded trial:\n\nOutcome assessor (CS) and Statistician. Participants couldn't be blinded because of the difference in the nature of interventions method of application."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2018-12-01', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral ulcer activity index', 'timeFrame': 'One month', 'description': 'Composite index score (0-10)'}], 'secondaryOutcomes': [{'measure': 'Oral health - related quality of life', 'timeFrame': 'One month', 'description': 'Oral health impact profile - 14 (OHIP- 14)'}, {'measure': 'Pain associated with oral ulcer', 'timeFrame': 'One month', 'description': 'Visual analogue scale (0-10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral ulcers'], 'conditions': ['Autoimmune', 'Behcet Syndrome']}, 'referencesModule': {'references': [{'pmid': '23622766', 'type': 'BACKGROUND', 'citation': 'Prasad R S, Pai A. Assessment of immediate pain relief with laser treatment in recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Aug;116(2):189-93. doi: 10.1016/j.oooo.2013.02.011. Epub 2013 Apr 23.'}, {'pmid': '24488418', 'type': 'BACKGROUND', 'citation': 'Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.'}, {'pmid': '34212234', 'type': 'DERIVED', 'citation': "Nagieb CS, Harhash TA, Fayed HL, Ali S. Evaluation of diode laser versus topical corticosteroid in management of Behcet's disease-associated oral ulcers: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):697-704. doi: 10.1007/s00784-021-04047-8. Epub 2021 Jul 2."}]}, 'descriptionModule': {'briefSummary': "Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.", 'detailedDescription': 'The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients diagnosed with Behcet's Disease according to International Criteria for BD.\n* patients with active oral ulcers.\n* patients free from any visible oral lesions other than the oral ulcers of BD.\n* patients who agreed to take the supplied interventions.\n* patients who will agree to participate in the study.\n* patients who will accept to sign the informed consent.\n\nExclusion Criteria:\n\n* patients not physically able to participate in survey or clinical oral examination.\n* patients with organ or life-threatening disease.\n* patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus.\n* patients under immunosuppressive drugs.\n* patients with organ transplantation."}, 'identificationModule': {'nctId': 'NCT03771768', 'acronym': 'BD', 'briefTitle': "Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Active Control,Randomized,Double- Blinded Clinical Trial of BD', 'orgStudyIdInfo': {'id': '3:5:1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone acetonide', 'description': 'Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.', 'interventionNames': ['Drug: Triamcinolone Acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'Diode laser', 'description': 'Diode laser 980 nm \\& 100mWatt.', 'interventionNames': ['Radiation: Diode laser 980nm&100 mWatt']}], 'interventions': [{'name': 'Diode laser 980nm&100 mWatt', 'type': 'RADIATION', 'otherNames': ['Low level laser', 'Biostimulation', 'Soft laser'], 'description': 'Diode laser 980 nm \\&100 milli Watt.', 'armGroupLabels': ['Diode laser']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'otherNames': ['Topical corticosteroid'], 'description': '0.1 \\&5gm paste 4 times/day', 'armGroupLabels': ['Triamcinolone acetonide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clair Sobhy Nagieb, MSC', 'role': 'CONTACT', 'email': 'Clair.nadieb@dentistry.cu.edu.eg', 'phone': '01222259819', 'phoneExt': 'Cairo U'}, {'name': 'Zaki S.Zaki, MSC', 'role': 'CONTACT', 'email': 'drzaki95@yahoo.com', 'phone': '01224045116'}], 'overallOfficials': [{'name': 'Sherin Ali Hassan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal invistigator', 'investigatorFullName': 'Clair Sobhy Nagieb Botros', 'investigatorAffiliation': 'Cairo University'}}}}