Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 11:52 AM
Study NCT ID:
NCT05951361
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2023-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054023', 'term': 'Lasers, Semiconductor'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-07', 'size': 904180, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-14T14:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'the patients were randomly assigned to avoid bios.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-16', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-07-16', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VAS', 'timeFrame': 'base line, 6weeks and 12 weeks', 'description': 'malondialdehyde is a strong marker for lipid peroxidation that can be measured in saliva to assess the effect of the treatment in oral lichen planus'}], 'primaryOutcomes': [{'measure': 'change of pain from the base line to 12 weeks follow-up', 'timeFrame': 'base line, 6weeks and 12 weeks', 'description': 'Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever'}], 'secondaryOutcomes': [{'measure': 'change of clinical score of the lesion from the base line to 12 weeks follow-up', 'timeFrame': 'base line, 6weeks and 12 weeks', 'description': 'The size of the lesion is monitored where score 0 no lesions, score 1 : mild white striation only, score 2 : white striation with erythematous area \\< 1 cm 2, score 3 : white striation with erythematous area \\> 1 cm 2, score 4 : white striation \\< 1 cm2, score 5 : white striation with erosive area \\> 1 cm2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Oral Lichen Planus']}, 'referencesModule': {'references': [{'pmid': '23549680', 'type': 'BACKGROUND', 'citation': 'Cafaro A, Arduino PG, Massolini G, Romagnoli E, Broccoletti R. Clinical evaluation of the efficiency of low-level laser therapy for oral lichen planus: a prospective case series. Lasers Med Sci. 2014 Jan;29(1):185-90. doi: 10.1007/s10103-013-1313-6. Epub 2013 Apr 3.'}, {'pmid': '24887747', 'type': 'BACKGROUND', 'citation': "Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002."}, {'pmid': '38365694', 'type': 'DERIVED', 'citation': 'Mohamed RK, Elsayed NM, Mahmoud SA, Gaweesh YY. Photobiomodulation versus corticosteroid in the management of erosive oral lichen planus: a randomized controlled clinical trial. BMC Oral Health. 2024 Feb 17;24(1):246. doi: 10.1186/s12903-024-03976-6.'}]}, 'descriptionModule': {'briefSummary': 'this study evaluates the effect of diode laser in treatment of oral lichen planus.', 'detailedDescription': '44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003.\n* Presence of painful erosive OLP lesions diagnosed by biopsy\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Patients currently treated for cancer with Chemotherapy or Radiotherapy\n* Patient currently on Corticosteroid therapy or had this treatment on the past 3 months\n* Those who had used Anti-inflammatory drugs topical or systemic in the last month\n* the use of drugs related to Oral Lichenoid Lesions\n* Presence of Amalgam restorations near the OLP lesions\n* dysplasia in histopathological examination\n* uncontrolled systemic diseases\n* physical or mental abnormality which would interfere with or be affected by the study procedure\n* Patients with skin lesion'}, 'identificationModule': {'nctId': 'NCT05951361', 'briefTitle': 'Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '0369-01/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Kenacourt-A Orabase', 'description': 'the patients in this group received steroid therapy" Kenacourt-A Orabase" three times daily for 4 weeks.\n\nantifungal drug "miconazole oral gel" once daily for 1 week', 'interventionNames': ['Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"']}, {'type': 'ACTIVE_COMPARATOR', 'label': '980nm Diode Laser', 'description': 'the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions', 'interventionNames': ['Device: 980nm Diode Laser']}], 'interventions': [{'name': '980nm Diode Laser', 'type': 'DEVICE', 'description': '300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions', 'armGroupLabels': ['980nm Diode Laser']}, {'name': '0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"', 'type': 'DRUG', 'otherNames': ['Kenacourt-A Orabase'], 'description': 'three times daily for 4 weeks', 'armGroupLabels': ['Kenacourt-A Orabase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21648', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Naguiba Mahmoud, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'department of oral medicine, faculty of dentistry'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The submission of data requests can commence nine months after the article has been published, and the data will be available for up to 24 months. Extensions will be reviewed on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Access to the data may be extended beyond the initial 24-month period upon request and approval, which will also be evaluated on a case-by-case basis.', 'accessCriteria': 'Qualified researchers who are conducting independent scientific research may request access to trial IPD. Upon review and approval of a research proposal and Statistical Analysis Plan (SAP), and the execution of a Data Sharing Agreement (DSA), access will be granted. For additional information or to request access, please contact the data provider. Approval for the extension of access beyond the initial 24-month period will also be considered on a case-by-case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}