[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-lichen-planus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-lichen-planus":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,39,74,98,123,156,188,215,240,270,294,326,351,376,407,436,462,487],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100591541","phase-2-effect-of-topical-bromelain-versus-topical-corticosteroids-in-the-management-of-oral-lichen-planus-100591541",false,"NCT06981767","Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus","Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients suffering from symptomatic OLP\n* Patients free from any visible oral lesions other than OLP.\n* Patients who agreed to take the supplied interventions.\n* Patient who will agree to participate in the study.\n* Patients who will accept to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients suffering from any systemic disease.\n* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.\n* Treatment with any oral topical medications for at least four weeks prior to the study.\n* Pregnant and lactating mothers.","ALL",{"count":18,"type":19},42,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to provide clinical evidence on the efficacy of bromelain for managing OLP, potentially offering a safer and more effective treatment option.",[25],"Oral Lichen Planus","RECRUITING","2026-06-08",{"date":29,"type":30},"2026-06-09","ACTUAL",{"date":32,"type":30},"2026-02-18",{"date":34,"type":19},"2026-08-15",{"name":36,"class":37},"Cairo University","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":38},"100639225","observational-study-of-orosedal-in-sore-throat-and-minor-oral-lesions-100639225","NCT07620353","Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions","Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study","Inclusion Criteria:\n\n* Age 8 years or older, including adults.\n* Sore throat or minor mouth lesion, including minor aphthous ulcer or histologically confirmed oral lichen planus, evolving for less than 15 days.\n* Global pain intensity over the previous 24 hours, spontaneous and\u002For during chewing or swallowing, \\>40 mm on a 0-100 mm visual analog scale.\n* OROSEDAL prescription decided by the investigator before inclusion.\n* Written informed consent from the patient or from one parent for minors.\n\nExclusion Criteria:\n\n* More than 3 visible oral mucosal lesions.\n* Post-intubation sore throat.\n* Corticosteroid use ongoing or within 3 days before inclusion.\n* NSAID use ongoing or within 3 days before inclusion.\n* Local treatment on the lesion ongoing or within 3 days before inclusion.\n* Non-opioid analgesics, including paracetamol, ongoing or within 3 days before inclusion, unless continued for at least 24 hours at the same daily dose as during the 24 hours before inclusion.\n* Weak or strong opioid analgesics ongoing or within 3 days before inclusion.\n* Signs suggesting a condition requiring additional investigations according to the investigator, except rapid streptococcal throat testing.\n* Signs suggesting a condition requiring corticosteroid prescription according to the investigator.\n* Systemic disease, such as rheumatoid arthritis, lupus, or Behçet disease.\n* Any contraindication listed in OROSEDAL instructions for use.\n* Known allergy to any OROSEDAL component, including glycerol, tamarind extract, mallow extract, benzyl alcohol, orange blossom flavoring, or xylitol.\n* Non-compliance with precautions for use listed in the instructions for use.","8 Years",{"count":48,"type":19},124,"OBSERVATIONAL","This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study will evaluate the performance and safety of OROSEDAL in children and adults with sore throat or minor oral lesions, including minor aphthous ulcers and histologically confirmed oral lichen planus. OROSEDAL is prescribed in routine practice before inclusion. Patients will be followed for 6 ± 1 days and will complete self-assessments of pain, swallowing discomfort, treatment use, and adverse events.",[52,53,25,54,55],"Sore Throat","Aphthous Ulcer","Minor Mouth Lesion","Oral Pain",[57,58,59,60,61,62,63],"sore throat","aphthous ulcer","mouth ulcer","oral lesion","PMCF","real-world evidence","swallowing discomfort","2026-05-27",{"date":66,"type":30},"2026-06-02",{"date":68,"type":30},"2026-03-05",{"date":70,"type":19},"2027-07",{"name":72,"class":73},"Laboratoires Elerte","INDUSTRY",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100637635","periodontal-status-in-patients-with-oral-lichen-planus-100637635","NCT07597616","Periodontal Status in Patients With Oral Lichen Planus","Studio Retrospettivo Monocentrico di Una Coorte di Pazienti Affetti da Lichen Planus Orale: Caratteristiche, comorbilità e Fattori di Rischio Per la Trasformazione Maligna","Inclusion Criteria:\n\n* OLP group (case)\n\nAge ≥ 18 years Clinical and histopathological diagnosis of OLP according to WHO criteria (2021)\n\nControl group\n\nAge ≥ 18 years Absence of clinical signs of OLP\n\nExclusion Criteria:\n\n* Both groups\n\nOral lichenoid lesions (OLL): oral lichenoid contact reactions (OLCR), lichenoid drug reactions (LDR), lesions associated with food\u002Fsubstances (e.g. cinnamon) Oral lesions associated with graft-versus-host disease (GVHD) History of haematopoietic stem cell transplantation (HSCT) Pregnancy Oncologic patients (including oral cancers) Smokers Diabetes mellitus Obesity Metabolic syndrome Immunosuppressive therapy Medications causing gingival hyperplasia\n\nControl group only\n\nImmune-mediated inflammatory diseases with oral involvement (e.g. psoriasis, systemic or discoid lupus erythematosus) Autoimmune oral diseases other than OLP\n\nOLP group only\n\nImmunosuppressive therapy for conditions other than OLP Autoimmune oral diseases other than OLP",true,"18 Years",{"count":84,"type":19},176,"This case-control study will enroll 176 patients age- and sex- matched at the Oral Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. There will be two groups: The control group will consist of 88 healthy patients enrolled among those routinely attending the dental outpatient clinic. An additional 88 patients diagnosed with OLP will form the case group. Both groups will undergo standard dental examinations, including periodontal probing. The primary objective is to evaluate whether patients with OLP present a higher prevalence and severity of periodontitis compared to healthy subjects. Secondary objectives include the assessment of gingivitis prevalence and RT1 gingival recessions in OLP patients compared with controls. Periodontal status will be assessed using major clinical indices and classified according to the 2017 AAP\u002FEFP case definition. The study aims to contribute evidence on the shared immune-inflammatory mechanisms underlying both conditions, with potential clinical implications for the integrated periodontal management of OLP patients.",[25,87],"Periodontitis","NOT_YET_RECRUITING","2026-05-19",{"date":91,"type":30},"2026-05-22",{"date":93,"type":19},"2026-05-20",{"date":95,"type":19},"2026-06-30",{"name":97,"class":37},"Catholic University of the Sacred Heart",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":38},"100587936","rate-of-malignant-transformation-and-clinical-characteristics-among-an-oral-lichen-planus-cohort-a-retrospective-center-experience-100587936","NCT06934863","Rate of Malignant Transformation and Clinical Characteristics Among an Oral Lichen Planus Cohort: a Retrospective Center Experience","Observational Study of an OLP Patients Cohort: Characteristics, Comorbidities, Risk Factors for Malignant Transformation","LPO_CMR","Inclusion Criteria:\n\n* Clinical-histological diagnosis of Oral lichen planus\n* Patients who gave consensus to personal data treatment\n* Minimum 6 months follow-up\n\nExclusion Criteria:\n\n* Patients who did not give consensus to personal data treatment\n* Oral lichenoid lesions\n* Patients with anamnesis of hematopoietic stem cells transplant\n* Patients with a OSCC at the first histological examination (i.e., namely: also OSCC patients with a OLP background were excluded)",{"count":107,"type":19},300,"The main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. Secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to OLP drgus.",[25,110,111],"Oral Carcinoma","Oral Carcinoma in Situ",[25,113,110,114],"Malignant Transformation","Oral Dysplasia","2026-05-12",{"date":117,"type":30},"2026-05-14",{"date":119,"type":30},"2024-01-31",{"date":121,"type":19},"2029-01-31",{"name":97,"class":37},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":20,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":38},"100614392","photobiomodulation-photodynamic-therapy-and-clobetasol-in-the-treatment-of-oral-lichen-planus-100614392","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.","20 Years","70 Years",{"count":133,"type":19},60,[135],"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.",[25,138,139],"Erosive Lichen Planus","Mucosal Lesions",[141,142,143,144,145,146],"Oral lichen planus","lichen planus","laser","Photobiomodulation therapy","steroids","PDT","2026-04-24",{"date":149,"type":30},"2026-04-30",{"date":151,"type":30},"2025-12-01",{"date":153,"type":19},"2026-11",{"name":155,"class":37},"Medical University of Silesia",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":20,"phases":166,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100583416","phase-2-low-cost-screening-and-image-guided-photodynamic-therapy-pdt-of-premalignant-and-malignant-oral-lesions-100583416","NCT06876038","Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions","A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting","Subject Inclusion Criteria\n\n1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.\n2. Willing and available for follow-up for at least one year and at prerequisite time intervals.\n3. All patients above the age of 18 years and willing to voluntarily give a signed informed consent.\n4. Karnofsky Performance Score above 80 or ECOG 0 or 1.\n5. The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual\n\n   * Hemoglobin level above or equal to 10%\n   * WBC \\>3000\u002Fmm3\n   * Platelets count \\>100000\u002Fmm3\n   * Total bilirubin, AST (SGOT), ALT (SGPT) \\\u003C 1.5 times the Upper Limit Normal\n   * eGFR \\> 60 ml\u002Fmin\n   * Serum Creatine less than 2 times the Upper Limit of laboratory normal\n   * INR\u002F PT and PTT within laboratory normal limits\n\nExclusion criteria:\n\n1. Hypersensitivity against active substances and porphyrins.\n2. Known diagnosis of porphyria.\n3. Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).\n4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.\n5. Subjects with inherited or acquired bleeding and clotting disorders\n6. Women who are breastfeeding\u002F have a positive urine pregnancy test or are planning their family.\n7. Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit.\n8. Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.\n9. Patients with behavioral and cognitive impairment.\n10. Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.\n11. Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.\n12. The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.\n13. Patient who was in a clinical trial for 4 weeks before participation in the present trial.","65 Years",{"count":165,"type":19},65,[22],"The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a \"Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:\n\n* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?\n* Do lesions recur after PDT treatment?\n* Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?",[169,170,171,25,172],"Oral Cancer","Oral Cavity Cancer","Oral Leukoplakia","Oral Squamous Cell Carcinoma",[174,175,176,177],"High grade dysplasia (HGD)","Severe\u002FModerate dysplasia","Carcinoma-in-situ (CIS)","Oral potentially malignant lesion (OPML)","2026-03-16",{"date":180,"type":30},"2026-03-19",{"date":182,"type":19},"2026-09",{"date":184,"type":19},"2028-12",{"name":186,"class":37},"University of Massachusetts, Boston",2,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":20,"phases":197,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":38},"100587781","the-therapeutic-effect-of-curcumin-in-nanogels-compared-to-01-fao-in-the-management-of-oral-lichen-planus-100587781","NCT06932848","The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus","The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% Fluocinolone Acetonide Oral Paste in the Management of Atrophic-Erosive Oral Lichen Planus","Inclusion Criteria:\n\n* Age 18 years or older\n* Ability to provide written informed consent\n* Clinically and histopathologically confirmed diagnosis of erosive or atrophic oral lichen planus (OLP)\n* Presence of symptoms (NRS pain score \\> 0 at baseline)\n* Ability to communicate and follow instructions\n* Willingness to apply oral paste treatment and comply with study protocol\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Current orthodontic treatment\n* Uncontrolled diabetes mellitus (HbA1c \\> 7% or FPG \\> 130 mg\u002FdL)\n* Use of anticoagulants or antiplatelet agents\n* Severe dry mouth (Challacombe score \\> 7)\n* History of gastric ulcers, duodenal ulcers, or gallstones\n* Presence of any active malignancy or infection\n* Use of topical\u002Fsystemic treatment for OLP in the past 2 weeks\n* Current use of immunosuppressants\n* Known allergy to corticosteroids or herbal agents such as turmeric\n* Diagnosis of oral lichenoid contact lesion or graft-versus-host disease (GVHD)\n* History of allogeneic bone marrow transplantation\n* Current smokers",{"count":196,"type":19},30,[135],"This randomized, double-blind clinical trial evaluates the therapeutic effects of curcumin in nanogels compared to 0.1% fluocinolone acetonide oral paste in the management of atrophic-erosive oral lichen planus (OLP). The study aims to determine whether curcumin nanogels, a natural treatment with enhanced bioavailability, are as effective and better tolerated than standard corticosteroid therapy.",[25],[201,202,203,204,205,206],"Atrophic-Erosive Oral Lichen Planus","Curcumin","Nanogels","Fluocinolone Acetonide","Mucosal Disease","Autoimmune Disease","2026-03-04",{"date":209,"type":30},"2026-03-06",{"date":211,"type":30},"2025-06-01",{"date":95,"type":19},{"name":214,"class":37},"Chulalongkorn University",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":20,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":38},"100622282","role-of-subgingival-instrumentation-in-oral-lichen-planus-100622282","NCT07381595","Role of Subgingival Instrumentation in Oral Lichen Planus","Impact of Subgingival Instrumentation on Clinical and Immunohistochemical Presentation of Oral Lichen Planus With Gingival Involvement","Inclusion criteria:\n\n* Clinically and histopathologically confirmed cases of OLP.\n* OLP predominantly involving the gingiva.\n* Consent obtained.\n\nExclusion criteria:\n\n* Cases which does not fulfil either clinical or histopathological criteria.\n* Unwilling to participate in the study.\n* Patients with recorded history of factors that might modify immune response (such as patient on corticosteroids or medically compromised patients or suffering from heart diseases).\n* Cases undergoing treatment of OLP within past 6 months.\n* Biopsies with inadequate or non-representative samples\n* Cases histopathologically diagnosed as Lichenoid Dysplasia or Oral Lichenoid Lesions.\n* Cases diagnosed with autoimmune disorders.",{"count":196,"type":19},[135],"The goal of this interventional study is to assess the clinical and histopathological changes in Oral Lichen Planus patients with gingival involvement pre and post subgingival instrumentation.\n\nObjective- Primary objective: To observe and evaluate the clinical signs and symptoms in Oral Lichen Planus with gingival involvement. Secondary objective: To observe and evaluate the Cluster of Differentiation (CD) 4+ and 8+T lymphocytes in Oral Lichen Planus with gingival involvement.\n\nStudy group: 30 cases of Oral Lichen Planus with gingival involvement",[25],[227,228,229,230],"Subgingival instrumentation","Immunohistochemistry","CD4 and CD8 lymphocytes","Clinical parameters","2026-02-04",{"date":233,"type":30},"2026-02-06",{"date":235,"type":19},"2026-03-01",{"date":237,"type":19},"2028-12-31",{"name":239,"class":37},"Postgraduate Institute of Dental Sciences Rohtak",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":20,"phases":249,"briefSummary":251,"conditions":252,"keywords":253,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":38},"100614503","phase-4-effectiveness-of-a-sodium-hyaluronate-001-and-sh-oligopeptide-85-sp-mouthwash-for-the-treatment-of-symptomatic-oral-lichen-planus-100614503","NCT07280442","Effectiveness of a Sodium Hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash for the Treatment of Symptomatic Oral Lichen Planus","Effectiveness of a Sodium Hyaluronate 0.01% and Sh-Oligopeptide-85 SP Mouthwash for the Treatment of Symptomatic Oral Lichen Planus. A Randomized Clinical Trial","Patients must meet the following inclusion criteria:\n\n1. Patients aged ≥18 years.\n2. Patients with a clinical and histological diagnosis of OLP according to the criteria of the American Academy of Oral and Maxillofacial Pathology (Cheng et al., 2016).\n3. Symptomatic patients, i.e., those presenting atrophic-erosive or ulcerative OLP lesions.\n4. Patients with a VAS score ≤ 6.\n\nExclusion criteria will be:\n\n1. Pregnant or breastfeeding women.\n2. Allergy to the components of the Tectum-11® mouthwash.\n3. Patients receiving corticosteroids, immunosuppressants, hydroxychloroquine, or retinoids at the time of recruitment.\n4. Patients with lichenoid lesions: drug-induced lichenoid reactions, contact lichenoid lesions, or graft-versus-host disease.\n5. Use of topical corticosteroids within the previous 4 weeks or systemic treatment within the previous 8 weeks.\n6. Use of other mouthrinses for plaque control.\n7. Patients unwilling to sign the informed consent form.\n8. Patients with a VAS score \\> 6.\n\nThe presence of any of the following criteria will lead to withdrawal of the participant from the study:\n\n1. Failure to attend follow-up visits.\n2. Occurrence of adverse events deemed clinically relevant by the investigator.\n3. The patient reports that they no longer wish to participate in the study.\n4. Development of oral or systemic lesions that meet any of the exclusion criteria.\n5. Non-adherence to the treatment regimen, defined as failure to follow the protocol for more than two consecutive weeks.",{"count":248,"type":19},40,[250],"PHASE4","Annex 1. Patient Information and Informed Consent for the Study Study Title: Effectiveness of a sodium hyaluronate 0.01% and Sh-Oligopeptide-85 SP mouthwash for the treatment of symptomatic oral lichen planus: a randomized clinical trial.\n\nPrincipal Investigator: Dr. Rosa Mª López-Pintor Muñoz, Associate Professor, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid.\n\nDear Sir\u002FMadam, Participants are invited to take part in a study evaluating the effectiveness of a mouthwash designed to reduce oral lichen planus-related lesions and pain.\n\nStudy Objective The primary aim of this study is to evaluate and compare the effect of Tectum mouthwash (containing sodium hyaluronate and Sh-Oligopeptide-85) versus a corticosteroid mouthwash (provided at no cost to participants) in reducing pain and lesion size.\n\nEligible participants with oral lichen planus and associated discomfort will receive either Tectum mouthwash or a corticosteroid mouthwash to use after toothbrushing for the first two weeks three times daily, twice daily in the third week, and once daily in the fourth week of treatment.\n\nParticipants will be randomly assigned to receive either Tectum mouthwash or the corticosteroid mouthwash through a process comparable to a coin toss. Treatment allocation will be blinded. Neither participants nor the attending clinician will know which treatment is being administered. Participants must use the assigned mouthwash for 4 weeks according to the clinician's instructions and attend visits at the Faculty of Dentistry at 1, 2, 3, and 4 weeks to assess improvement.\n\nAt the first visit, a series of data will be recorded, and oral lichen planus lesions and pain will be assessed. The same variables will be evaluated at 1, 2, 3, and 4 weeks to determine treatment effectiveness. Participants will also complete two questionnaires assessing pain intensity and the impact of symptoms on quality of life. During the 4-week treatment period, the use of any other mouthwashes will not be permitted, and antibiotics or anti-inflammatory medications may not be used.\n\nThe investigational mouthwash is already marketed and has been used to treat conditions such as oral mucositis and xerostomia with favorable results; therefore, potential benefit in oral lichen planus is anticipated.\n\nIf pain occurs, 400 mg ibuprofen may be taken every 8 hours as needed. If ibuprofen is taken, each dose should be recorded and reported to the attending healthcare professional.\n\nVoluntary Participation Participation is entirely voluntary, and non-participation is permitted. Participants may withdraw at any time without providing an explanation and without any disadvantage to clinical care. Refusal to participate or withdrawal will not affect the relationship between participants and the institution.\n\nStudy Procedures The dentist providing care in the Diploma of Specialization in Oral Medicine will invite eligible individuals to participate and will provide detailed instructions. The attending dentist will request completion of a questionnaire containing study-required information. If participation is accepted, lesions will be assessed, and questionnaires will be completed.\n\nThe attending dentist will instruct participants on product use: three times daily during weeks 1 and 2, twice daily during week 3, and once daily during week 4. Follow-up appointments at 1, 2, 3, and 4 weeks will be scheduled to evaluate the same variables and to repeat the questionnaires.\n\nRisks This study does not present additional risks beyond routine care. Improvement may not occur with use of the mouthwash. Response to corticosteroids and to the investigational treatment may vary.\n\nConfidentiality Confidentiality will be maintained. All information collected during this research will be treated as privileged and documented in coded format. Participants have the right to access and rectify personal data at any time, as established by Organic Law 3\u002F2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights. In accordance with data protection regulations, consent may be revoked and rights of access, modification, opposition, and deletion of data may be exercised. Rights to limit the processing of inaccurate data, request a copy of the data, or request transfer of data to a third party (portability), as applicable, may also be exercised.\n\nTo exercise these rights, contact may be made with the principal investigator (Dr. Rosa Mª López-Pintor Muñoz, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid). Participants may also contact the Spanish Data Protection Agency if concerns are not resolved satisfactorily.\n\nParticipant identity and any information that could identify a participant will not be disclosed.",[25],[254,255,256,257,258,259,260],"oral lichen planus","RCT","OPMD","treatment","topical treatment","Sh-Oligopeptide-85 SP Mouthwash","Sodium hyaluronate 0.01%","2026-01-14",{"date":263,"type":30},"2026-01-16",{"date":265,"type":19},"2026-01-08",{"date":267,"type":19},"2027-06-15",{"name":269,"class":37},"Universidad Complutense de Madrid",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":4},"100604553","cardiovascular-and-prothrombotic-risk-in-patients-with-oral-lichen-planus-100604553","NCT07151014","Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.","Prospective Single-center Study of a Cohort of Patients With Oral Lichen Planus: Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus (OLP).","LPO_RCP","Inclusion Criteria:\n\n* Patients with a clinical and histological diagnosis of Oral Lichen Planus\n* Age \\> 18 years\n* Patients who agree to sign the informed consent form\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients who do not agree to sign the informed consent form\n* Patients without a diagnosis of Oral Lichen Planus\n* Patients with previously known cardiac diseases\n* History of major cardiovascular events (myocardial infarction, ischemic stroke, TIA)\n* Patients with overt heart failure (NYHA class III-IV)\n* Cardiomyopathies not related to the studied risk factors (e.g., genetic hypertrophic cardiomyopathy)\n* Patients undergoing anticoagulant therapy\n* Patients with primary or secondary conditions associated with increased cardiovascular risk",{"count":279,"type":19},55,"The primary objective is to evaluate the cardiovascular profile and the risk of thrombotic events in patients affected by Oral Lichen Planus.",[25],[254,283,284],"Prothrombotic risk","trombophilia screening","2026-01-09",{"date":287,"type":30},"2026-01-12",{"date":289,"type":19},"2026-01",{"date":291,"type":19},"2027-02-15",{"name":293,"class":37},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100617461","evaluation-of-artificial-intelligence-in-diagnosis-and-risk-assessment-of-oral-potentially-malignant-disorders-100617461","NCT07318922","Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders","Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders Using Clinical and Exfoliative Cytology Imaging","Inclusion Criteria:\n\n1- Patients have no signs of super infection of candida on the lesions. 2- A lesion with a provisional clinical diagnosis of (OLP, OLK, OEP, non-healing ulcers) at any site in the oral cavity (buccal mucosa, hard palate, labial mucosa, tongue, gingiva).\n\n\\-\n\nExclusion Criteria:\n\n* Any other mucosal lesions.","30 Years","75 Years",{"count":304,"type":19},120,"Oral potentially malignant disorders (OPMDs) are mucosal lesions that carry a risk of malignant transformation into oral cancer. Unfortunately, a general lack of knowledge and awareness of OPMDs is common among general dental practitioners. While thorough clinical examinations coupled with biopsy can identify most OPMDs, the absence of reliable non-invasive diagnostic tools and standardized risk stratification often delays early diagnosis and treatment of oral squamous cell carcinoma (OSCC).Early detection of suspicious oral lesions is crucial for reducing OSCC-related mortality and improving patient outcomes. Histopathological assessment of biopsied tissue remains the gold standard for diagnosis. However, since biopsy is invasive and may be associated with patient discomfort; numerous noninvasive diagnostic technologies have emerged to enhance the detection and diagnosis of oral mucosal lesions.Toluidine blue (TB) staining is one such adjunctive tool, where the degree of color retention aids in lesion characterization. Dark blue staining is considered positive for lesions highly suspicious for malignancy; light blue retention is considered positive for premalignant lesions pending histopathological confirmation, while lesions showing no stain retention are classified as negative.Exfoliative cytology represents another non-invasive diagnostic approach, wherein cells obtained via brushing the oral mucosa are spread on a slide for cytological evaluation. This technique, widely accepted and increasingly utilized, has proven valuable for early cancer detection. Notably, confocal microscopy has demonstrated high sensitivity and specificity (93%) in detecting malignant cells in exfoliative cytology specimens. Currently, TB staining and confocal microscopy remain the most commonly utilized non-invasive screening techniques in clinical practice.In recent years, artificial intelligence (AI) applications have shown remarkable promise in oncology, achieving high diagnostic accuracy across various cancer types. Deep learning models, in particular, offer exceptional performance, suggesting that AI-based solutions may be feasible for widespread community screening programs following further validation. In many cases, AI models have produced diagnostic outcomes that match or surpass those of experienced pathologists. Moreover, the combined application of AI with expert human evaluation has been shown to reduce diagnostic errors and improve diagnostic precision, particularly for poorly differentiated tumors and rare cases.Several studies have been done using different AI Models and revealed a promising application of AI in diagnosing OPMDs and cancers in different body sites.",[25,171,307,308],"Traumatic Ulcer of Oral Mucosa","Erythroleukoplakia of Mouth",[310,311,312,313,314,315,316],"OPMDs","Artificial Intelligence","Toluidine blue stain","Confocal microscope","Exfoliative Cytology","Acridine orange stain","Tissue biopsy","2025-12-20",{"date":319,"type":30},"2026-01-06",{"date":321,"type":19},"2025-12-16",{"date":323,"type":19},"2026-12-20",{"name":325,"class":37},"Ain Shams University",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":20,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":38},"100603076","phase-4-evaluation-of-efficacy-and-safety-of-add-on-tofacitinib-in-patients-with-oral-lichen-planus-100603076","NCT07131813","Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus","Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients aged ≥18 of either sex with the clinical diagnosis of oral lichen planus.\n* Patients with a PGA score of ≥3 (moderate and severe oral LP).\n* Patients who are willing to give informed written consent.\n\nExclusion Criteria:\n\n* Treatment with a systemic corticosteroid within the last 4 weeks.\n* Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment.\n* Patients with a clinical history and any lesion distribution suspicious of a lichenoid drug eruption, and patients with other skin diseases.\n* Past or current history of any malignancy, including moderate to severe dysplasia of the oral mucosa on oral biopsy.\n* Severe active infection, including active tuberculosis, hepatitis B, or C infection\n* Patients with cytopenia (Hb \\\u003C9g\u002Fdl, leukocyte count \\\u003C4000\u002Fmm3, platelet count \\\u003C100,000\u002Fmm3)\n* The patient with a history of alcohol abuse.\n* Decreased liver or renal function (creatinine \\> 2.0mg\u002Fdl, total bilirubin \\> 2.5 mg\u002Fdl).\n* Severe acute infection, uncontrolled diabetes mellitus, congenital or acquired immunodeficiency, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia, or depression.\n* Patient with a history of hypersensitivity to topical Triamcinolone or Tofacitinib.\n* Pregnancy and lactation, women of childbearing age without effective contraception.",{"count":133,"type":19},[250],"Many of the patients with oral lichen planus (OLP) either fail to achieve complete remission or experience frequent relapses with conventional topical corticosteroid therapy, which is currently the mainstay of treatment. Long-term corticosteroid use is limited by local and systemic adverse effects, and many patients develop steroid resistance or intolerance. To overcome these limitations, combination therapy with agents having complementary mechanisms may improve therapeutic outcomes, reduce steroid requirements, and minimize associated adverse effects. Tofacitinib, a Janus kinase (JAK1\u002FJAK3) inhibitor, modulates the JAK-STAT signaling pathway, thereby reducing inflammatory cytokine production involved in OLP pathogenesis. Preliminary case series and pilot trials have shown promising results with tofacitinib in OLP. However, to date, no randomized controlled trial has evaluated the efficacy and safety of add-on oral tofacitinib with standard topical steroid therapy in OLP. Hence, investigators considered tofacitinib to be a candidate drug for add-on therapy due to its anti-inflammatory and immunomodulatory properties. Adding tofacitinib to ongoing topical triamcinolone therapy may increase the response rate, reduce adverse drug reactions by lowering steroid dose requirements, or achieve a quicker therapeutic effect. Therefore, the present randomized controlled trial has been planned to evaluate the efficacy and safety of oral tofacitinib as an add-on therapy in patients with OLP.",[25],[338,25,339,340,341],"Tofacitinib","Randomized Controlled Trial","Placebo","IL 6","2025-11-26",{"date":344,"type":30},"2025-11-28",{"date":346,"type":30},"2025-10-10",{"date":348,"type":19},"2027-06-01",{"name":350,"class":37},"All India Institute of Medical Sciences, Bhubaneswar",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":358,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":20,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100600642","phase-4-efficacy-of-coconut-gel-compared-to-corticosteroid-gel-in-the-management-of-oral-lichen-planus-100600642","NCT07100145","Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus","Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus (A Randomized Controlled Clinical Trial With Biochemical Analysis)","Inclusion Criteria:\n\n* Clinically and histologically proven Bullous\u002Ferosive or atrophic forms of OLP.\n\nExclusion Criteria:\n\n* lichenoid lesions.\n* Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.\n* Smoking.\n* Known hypersensitivity to the treatment drugs or any of the ingredients.\n* Pregnancy or breast-feeding.\n* History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs in the last 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.\n* Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.\n* Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.\n* Vulnerable groups (handicapped, orphans and prisoners).","25 Years","60 Years",{"count":196,"type":19},[250],"In oral lichen planus ,Tumor necrosis factor-alpha (TNF-α) has a role in the progression of the disease, enhancing CD8+ cytotoxic T cells and plays a role in the malignant transformation of the lesion. IL-10 is an anti-inflammatory cytokine that controls the disease and maintain homeoastasis. Treatment for OLP includes corticosteroids which is the gold standard, although they have considerable side effects. The use of herbal medicine as an alternative therapy seems promising. Coconut oil has anti-inflammatory, antioxidant, and immunomodulatory properties, no adverse effects, easily available, cost-effective and simply extracted.The aim of this randomized controlled clinical trial is to compare the therapeutic effects of topical 50% coconut mucobioadhesive gel versus topical corticosteroid gel in the management of symptomatic OLP clinically and using biochemical analysis",[25],[141,365,366,367],"coconut oil","TNF-alpha","IL-10","2025-08-01",{"date":370,"type":30},"2025-08-06",{"date":372,"type":19},"2026-01-01",{"date":374,"type":19},"2027-12-01",{"name":325,"class":37},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":20,"phases":386,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":38},"100600678","phase-2-mucoadhesive-modified-release-formulations-for-the-topical-treatment-of-symptomatic-oral-lichen-planus-100600678","NCT07100613","Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus","Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)","EMPATIA","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Clinical suspicion of Oral Lichen Planus (OLP).\n* Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria).\n* Absence of epithelial dysplasia.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Previous diagnosis or treatment for OLP.\n* Use of topical or systemic corticosteroids in the last 4 weeks.\n* Use of medications known to cause lichenoid reactions.\n* History of allergic reactions to dental materials (e.g., amalgam).\n* Hematological disorders or immunodeficiencies.\n* Pregnancy or breastfeeding.\n* Current use of immunosuppressive therapies.\n* Inability or unwillingness to comply with study procedures.",{"count":385,"type":19},45,[22],"The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:\n\nDoes the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?\n\nResearchers will compare:\n\nA patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base\n\nParticipants will:\n\nApply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience",[25,389,390,55],"Oral Lichen Planus Related Stress","Oral Mucosal Disease",[392,254,393,394,395,396,397],"mucoadhesive patch","clobetasol","resveratrol","drug delivery system","Optical coherence tomography","Ora pain","2025-07-30",{"date":400,"type":30},"2025-08-03",{"date":402,"type":30},"2024-09-04",{"date":404,"type":19},"2027-10-01",{"name":406,"class":37},"University of Palermo",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":38},"100540758","systematical-trained-learning-algorithms-for-oral-carcinogenesis-interpretation-by-optical-coherence-tomography-100540758","NCT06321003","SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography","Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer","SYMILIS OCT","Inclusion Criteria:\n\n1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC).\n2. Patients able to provide informed consent for participation in the study.\n3. Availability of complete clinical data and medical records.\n\nExclusion Criteria:\n\n1. Patients with a previous diagnosis of OSCC\u002FOPMDs and\u002For who have already undergone treatment.\n2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe.\n3. Pregnant or breastfeeding women.\n4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.","99 Years",{"count":417,"type":19},200,"This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.\n\nThe trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.\n\nFurthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.\n\nIn summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.",[172,420,171,421,25,422,423,424,425,426,169,427],"Oral Potentially Malignant Disorder","Proliferative Verrucous Leukoplakia","Oral Lichenoid Lesion","Graft-versus-host-disease","Oral Erythroplakia","Actinic Keratoses","Actinic Cheilitis","Oral Disease","2025-05-19",{"date":430,"type":30},"2025-05-23",{"date":432,"type":30},"2024-03-13",{"date":434,"type":19},"2028-04-01",{"name":406,"class":37},{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":302,"enrollmentInfo":443,"targetDuration":4,"studyType":20,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":38},"100554368","periodontal-initial-treatment-combined-with-glucocorticoid-therapy-for-erosive-oral-lichen-planus-100554368","NCT06498180","Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus","A Randomized Self-control Study of Periodontal Initial Treatment Under Local Anesthesia Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus","Inclusion Criteria:\n\n* Existence of erosive oral lichen planus that lasts for more than 2 months\n* Erosive lesions are located in the buccal mucosa and gingival buccal sulcus of the bilateral mandibular posterior teeth area\n* The erosive lesions are mild to moderate (single or multiple small area erosions; 3mm ≤ longest diameter ≤ 10mm; 9mm2 ≤ total area of erosions ≤ 100mm2), and the degree of erosion on both sides is similar (the difference in the size of erosion on both sides does not exceed ± 25%)\n* The plaque index in the area of erosive lesions is ≥ 3; Dental calculus index ≥ 2; Gingival index ≥ 2;\n* Accompanied by stage II-IV extensive periodontitis\n\nExclusion Criteria:\n\n* Pregnant women, lactating women, or women planning to conceive during the trial period\n* Patients with coagulation dysfunction or other uncontrolled systemic diseases who cannot undergo periodontal treatment\n* Has undergone basic periodontal treatment within the past 6 months\n* Individuals with a history of allergy to local anesthetic drugs such as articaine\n* Individuals with contraindications to glucocorticoids\n* Patients with lesion area erosion caused by trauma or chemical stimulation\n* Patients with mental disorders who are difficult to cooperate with treatment",{"count":444,"type":19},29,[135],"The purpose of this clinical trial is to understand whether the combination of periodontal initial treatment under local anesthesia and glucocorticoids can improve the effectiveness of treatment for erosive oral lichen planus. It will also understand the safety of this treatment regimen.\n\nThis study is a single-center, parallel-group, randomized self-controlled trial. The researchers will compare the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia with traditional glucocorticoid therapy to see if the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia promotes the healing of erosive oral lichen planus.\n\nParticipants will:\n\nOne side received periodontal initial treatment combined with glucocorticoid under local anesthesia, while the other side received traditional glucocorticoid therapy Clinical examination at 2, 4, 8, and 12 weeks after treatment Note down the size of their erosion lesion area and periodontal clinical parameters",[25,448],"Periodontal Diseases",[450,451,452],"Periodontal initial therapy","Erosive oral lichen planus","Local anesthesia","2024-07-11",{"date":455,"type":30},"2024-07-12",{"date":457,"type":19},"2024-12-31",{"date":459,"type":19},"2028-03-31",{"name":461,"class":37},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":81,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":20,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":38},"100514024","treatment-of-oral-lichen-planus-with-paeoniflorin-and-photodynamic-therapy-100514024","NCT05973097","Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy","Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy","Inclusion Criteria:\n\n* patients with oral lichen planus\n* male or female patients older than 18 years of age\n* patients willing to participate with signed informed consent.\n\nExclusion Criteria:\n\n* pregnant or lactating\n* had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors\n* were unwilling to participate in the experiment.",{"count":470,"type":19},156,[135],"Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral mucosa and is considered a precancerous condition. It is characterized by white reticular changes in the oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease. Currently, only symptomatic treatments are available, and there is no definitive cure.\n\nIn this project, we plan to use TCM differentiation to categorize OLP patients and conduct a randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project will provide new insights into the clinical management of OLP, improve our understanding of the treatment mechanisms, and have important theoretical and clinical implications.",[25],[254,475,476,477],"integrated Chinese and Western medicine","total glucosides of paeony","photodynamic therapy","2023-07-25",{"date":480,"type":30},"2023-08-02",{"date":482,"type":19},"2023-07-30",{"date":484,"type":19},"2028-12-30",{"name":486,"class":37},"Peking University Third Hospital",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":495,"enrollmentInfo":496,"targetDuration":498,"studyType":49,"phases":4,"briefSummary":499,"conditions":500,"keywords":503,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":38},"100360606","prediction-of-malignant-transformation-of-oral-leukoplakia-using-a-mage-a-based-immunoscore-100360606","NCT03975322","Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore","Prospective Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore","PREDICT-OLP","Inclusion Criteria:\n\n* Adults, consenting male or female patients\n* Age 18 - 80 years\n* Diagnosis of one or more leukoplakia of the oral cavity\n\nincluding\n\n* leukoplakia associated wit lichen planus OR\n* leukoplakia associated with diseases of the immune system or immunosuppression OR\n* leukoplakia associated with a malignoma of other sites (except oral cavity) in the anamnesis\n* Existing consent to participation in the study after clarification has been given\n\nExclusion Criteria:\n\n* clinical evidence of invasive carcinoma of the oral cavity OR\n* carcinoma of the oral cavity in the anamnesis OR\n* patients unable to give informed consent OR\n* rejection of the patient","80 Years",{"count":497,"type":19},500,"3 Years","Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Early detection and prevention of OSCC is thought to have the highest potential to reduce morbidity and mortality. In prevention, the main focus is on precancerous lesions, especially oral leukoplakia (OLP), as up to 67% of OSCC arise on the basis of OLP. The determination of the transformation risk of OLP by histological determination of the degree of dysplasia is unreliable.\n\nA promising marker for the timely development of a OSCC is the detection of antigens of the MAGE-A gene family. The special feature of MAGE-A is that they can be detected in 93% of all OSCC and in approx. 85% of OLP that transform to OSCC. The detection of MAGE-A could also indicate changes in the immunological environment that occur prior to malignant OLP transformation and could be used for immunotherapies.\n\nAim of this study is to investigate MAGE-A as a predictive marker for the malignant transformation of OLP in the setting of a prospective, multicenter study and to establish it as a diagnostic parameter in addition to classical histology. In addition, the association of MAGE-A expression with the occurrence of immunological changes in OLP will be investigated in order to evaluate the possibility of minimally invasive immunotherapy of OLP.\n\nThe study is intended to include 500 biopsies of non-selected patients with OLP from university institutions and private practices. The follow-up should be at least 3 years, whereby it is examined whether an OSCC on the basis of the original OLP developed. After three years, an interim evaluation of the results with statistical evaluation will be carried out. In order to ensure that the course of the disease is monitored for at least three years for all OLPs, an extension of the monitoring period to 5 years is planned.\n\nThe study could establish a routine diagnostic parameter to supplement the histo-morphological diagnosis of OLP and evaluate the possibility of immunotherapy of OLP.",[171,501,502,25],"Oral Leukoplakia of Tongue","Oral Leukoplakia of Gingiva",[504,505,506,507],"OLP","oral cancer","OSCC","oral squamous cell carcinoma","2019-12-02",{"date":510,"type":30},"2019-12-03",{"date":512,"type":30},"2019-12-01",{"date":514,"type":19},"2026-12-30",{"name":516,"class":37},"University of Erlangen-Nürnberg Medical School"]