[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614392":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":56,"locations":66,"responsibleParty":84,"collaborators":37,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":37,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":37,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":69,"whyStopped":37,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation (PBM)","EXPERIMENTAL","Participants in this arm receive photobiomodulation using a 635 nm diode laser delivered in continuous mode. Energy parameters follow a fixed protocol with 4 J\u002Fcm² fluence, 100 mW power, and 15 seconds per treatment point using a noncontact technique. Applications are performed twice weekly until complete epithelial healing or a maximum of eight sessions. This arm evaluates the regenerative and anti-inflammatory effects of PBM for erosive oral lichen planus.",[13],"Device: Photobiomodulation using 635 nm diode laser",{"label":15,"type":10,"description":16,"interventionNames":17},"Photodynamic Laser Therapy - TBO mediated","Participants in this arm undergo Photodynamic Therapy using toluidine blue as a photosensitizer activated by a 635 nm diode laser. The protocol applies the photosensitizer in gel form under an occlusive dressing for ten minutes, followed by point-by-point irradiation at a fluence of 120 J\u002Fcm² using a glass fiber tip of 8 mm diameter, targeting pathologically altered mucosal tissue while minimizing damage to surrounding healthy epithelium. Treatment is performed once weekly for six consecutive sessions. This arm evaluates whether PDT-mediated photochemical action supports lesion resolution, symptom reduction, and sustained remission in erosive oral lichen planus.",[18],"Device: Photodynamic therapy - laser mucosal treatment",{"label":20,"type":10,"description":21,"interventionNames":22},"Topical Clobetasol 0.05 percent","Participants receive standard therapy with topical clobetasol propionate 0.05 percent. The medication is applied to clean, dry oral mucosa twice daily for thirty days following clinical guidelines for erosive oral lichen planus. This arm serves as the comparator for evaluating the effectiveness of laser-based treatments relative to established corticosteroid therapy.",[23],"Drug: Clobetasol propionate 0.05 percent topical application",[25,33,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Photobiomodulation using 635 nm diode laser","Photobiomodulation is delivered with a 635 nm diode laser in continuous mode at 100 mW, fluence 4 J\u002Fcm², and power density 0.2 W\u002Fcm². Each point is irradiated for 15 seconds using a noncontact technique with an 8 mm flat glass fiber tip and a 0.5 cm² spot size. Treatment points are spaced 2-3 mm apart over the lesion surface. Sessions are performed twice weekly until complete epithelial healing or for a maximum of eight sessions. This intervention aims to modulate inflammation and support mucosal repair in erosive oral lichen planus.",[9],[31,32],"PBM laser therapy","Low level laser therapy (LLLT)",{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Photodynamic therapy - laser mucosal treatment","Photodynamic Therapy is performed using toluidine blue gel as a photosensitizer, applied to the affected mucosal surface under an occlusive dressing for ten minutes. Following removal of the dressing and excess photosensitizer, irradiation is carried out using a 635 nm diode laser (Smart M®, Lasotronix) operating in continuous-wave mode at an output power of 400 mW and a power density of 0.8 W\u002Fcm². A flat glass fiber tip of 8 mm diameter is used in a noncontact mode at a distance of approximately 1 mm from the lesion surface. Irradiation is applied point by point at a fluence of 120 J\u002Fcm² per point, with the duration of each point irradiation set at 2 minutes and 32 seconds; the total number of points and overall session duration are determined by lesion extent. Following irradiation, the photosensitizer is left in place for an additional three minutes before removal by oral rinsing with water. Sessions are conducted once weekly for six consecutive treatments. This intervention evaluat",[15],null,{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Clobetasol propionate 0.05 percent topical application","Participants apply clobetasol propionate 0.05 percent directly to clean, dry oral mucosa twice daily for thirty days. The medication is used according to standard clinical practice for erosive oral lichen planus. The formulation serves as the active comparator to evaluate how laser-based treatments perform relative to conventional corticosteroid therapy. Participants are instructed to avoid eating, drinking, or rinsing for at least 30 minutes after application to ensure adequate mucosal contact.",[20],[44],"Topical corticosteroid",[46,50,53],{"name":47,"affiliation":48,"role":49},"Dariusz Skaba","Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia","STUDY_CHAIR",{"name":51,"affiliation":48,"role":52},"Jakub Fiegler-Rudol","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":48,"role":55},"Rafał Wiench","STUDY_DIRECTOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":37,"email":61},"Jakub Fiegler-Rudol, PhD candidate","CONTACT","0048531770099","jakub.fieglerrudol@gmail.com",{"name":63,"role":59,"phone":64,"phoneExt":37,"email":65},"Rafał Wiench, Professor, DMD, PhD","0048574004884","rwiench@sum.edu.pl",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Department of Periodontology and Oral Mucosa Diseases","RECRUITING","Zabrze","Silesian Voivodeship","41-800","Poland","PL",{"type":76,"coordinates":77},"Point",[78,79],18.78576,50.32492,{"lat":79,"lon":78},[82],{"name":54,"role":59,"phone":83,"phoneExt":37,"email":65},"+48 531 770 099",{"type":85,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100614392","photobiomodulation-photodynamic-therapy-and-clobetasol-in-the-treatment-of-oral-lichen-planus-100614392",false,"NCT07278999","Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.","Effectiveness of Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of the Erosive Form of Oral Lichen Planus - a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Be between 20 and 70 years old.\n* Have histologically confirmed erosive or ulcerative oral lichen planus based on a biopsy.\n* Have no active aerobic bacterial infection or oral fungal infection.\n* Have had no treatment for OLP within the past 3 months.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Systemic diseases or conditions such as uncontrolled diabetes (random glucose ≥200 mg\u002Fdl), cardiovascular failure, or a pacemaker.\n* Autoimmune\u002Fconnective tissue diseases such as lupus with positive ANA testing.\n* Current or past cancer, graft-versus-host disease, or hematologic disorders (anemia, leukemia, lymphoma, bleeding disorders, hemophilia, von Willebrand disease).\n* Enzymatic or metabolic disorders such as G6PD deficiency (favism) or porphyria.\n* Viral hepatitis A, B, or C.\n* Recent vaccinations (within the past 6 months).\n* Use of medications known to trigger lichenoid reactions, including:\n* Antihypertensives (beta-blockers, diuretics, ACE inhibitors, centrally acting agents).\n* Oral antidiabetics (sulfonylureas).\n* Metal-containing compounds (lithium, gold, arsenic, mercury).\n* NSAIDs (e.g., ibuprofen).\n* Antibiotics\u002Fchemotherapeutics (tetracyclines, sulfonamides).\n* Pregnancy or breastfeeding (including up to 6 months post-lactation).\n* Photosensitivity to UV light.\n* Smoking more than 5 cigarettes per day.\n* Lesions located adjacent to amalgam fillings or metal prosthetic restorations.\n* Any degree of dysplasia on histopathology.\n* Treatment for OLP within the last 3 months.\n* Active oral fungal or bacterial infection at screening.\n* Lack of consent to participate.","ALL","20 Years","70 Years",{"count":97,"type":98},60,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study aims to compare three treatment approaches for the erosive form of oral lichen planus, a chronic inflammatory condition that often causes pain, impaired oral function, and frequent relapses. Sixty adults with a confirmed diagnosis will be randomly assigned to photobiomodulation, Photodynamic Therapy, or topical clobetasol, which serves as the current standard of care. The project investigates how effectively each method promotes healing of erosive lesions, reduces pain, improves oral functions such as chewing and swallowing, and prevents recurrence after treatment. Before enrollment, participants will undergo microbiological testing, tissue autofluorescence assessment, and histopathological confirmation. Treatment will follow strict protocols tailored to each therapy type, with PBM applied twice weekly, PDT administered once weekly for six consecutive weeks using toluidine blue as a photosensitizer activated by a 635 nm diode laser, and clobetasol used twice daily for thirty days. Clinical outcomes will be measured using lesion size, standardized scoring systems, and patient-reported scales for pain and swelling. Follow up at one week, one month, and three months will document healing progress and relapse rates. Safety monitoring includes evaluation for infections and adverse reactions. The expected outcome is to determine which therapy provides the most effective, safe, and durable improvement. The study may offer evidence supporting laser based methods as alternatives that avoid the risks associated with long term steroid use.",[104,105,106],"Oral Lichen Planus","Erosive Lichen Planus","Mucosal Lesions",[108,109,110,111,112,113],"Oral lichen planus","lichen planus","laser","Photobiomodulation therapy","steroids","PDT","2026-04-24",{"date":116,"type":117},"2026-04-30","ACTUAL",{"date":119,"type":117},"2025-12-01",{"date":121,"type":98},"2026-11",{"name":5,"class":6},1]