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NCT07536737
Oral lichen planus (OLP) is a chronic inflammatory disease that affects the lining of the mouth and may cause pain, burning sensations, and discomfort. Some patients also report changes in their ability to taste different flavors. The aim of this study is to compare two commonly used treatments for OLP: photodynamic therapy (PDT) and topical corticosteroids. PDT is a light-based treatment that uses a special gel applied to the affected areas, followed by illumination with a medical light device. Topical corticosteroids are anti-inflammatory medications applied directly to the lesions. Participants in this study are randomly assigned to receive one of these two treatments. Before starting therapy and immediately after its completion, patients undergo a simple taste test using special strips that assess the ability to recognize sweet, sour, salty, and bitter tastes. In addition, the size of oral lesions and the intensity of symptoms such as pain or burning are evaluated. The results of this study may help to better understand how different treatments for oral lichen planus affect taste perception and overall patient well-being, and may support the selection of the most appropriate therapy in clinical practice.
NCT05401201
This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).
NCT06932848
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.
NCT07381595
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. Objective- 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. Study group: 30 cases of Oral Lichen Planus with gingival involvement
NCT07280442
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. Principal Investigator: Dr. Rosa Mª López-Pintor Muñoz, Associate Professor, Department of Clinical Dental Specialties, Faculty of Dentistry, Complutense University of Madrid. Dear Sir/Madam, 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. Study 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. Eligible 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. Participants 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. At 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. The 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. If 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. Voluntary 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. Study 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. The 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. Risks 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. Confidentiality 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 3/2018 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. To 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. Participant identity and any information that could identify a participant will not be disclosed.
NCT07318922
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.
NCT07131813
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/JAK3) 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.
NCT05403216
On the basis of previous studies, a validation cohort will be established to explore the relationship between oral lichen planus and autoimmune thyroid diseases, and a disease efficacy prediction strategy can be formed.
NCT07137156
Lichen planus is a common chronic mucocutaneous inflammatory disease that affects the skin, nails, eyes, urogenital system, and oral mucosa. Oral lichen planus (OLP) specifically occurs in the oral cavity. As a variant of lichen planus, OLP is believed to affect the oral mucosa through T-cell-mediated chronic inflammation, and some researchers suggest that Th2-mediated inflammation may also contribute to its pathogenesis. The absence of metagenomic analyses targeting oral microbiome profiling in OLP patients in Türkiye highlights the need for studies in this field. This pilot study, conducted for the first time in Türkiye, examined microbial diversity and dominant bacterial families in the lesional and non-lesional oral sites of Turkish individuals with OLP, compared with healthy individuals. The findings are expected to contribute to identifying potential microbial targets that may play a role in OLP pathogenesis and to shaping future treatment strategies.
NCT07114016
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan. It is classified as a nutraceutical and it is used mainly orally for the therapy of osteoarthritis since GlcN has immunoregulatory capacity and anti-inflammatory effects. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared the clinical efficacy of topical glucosamine to topical corticosteroid in the treatment of symptomatic OLP and investigated the effect of these two treatment modalities on the expression of tumor necrosis factor-alpha (TNF-α) in oral lichen planus lesions
NCT06321003
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. The 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. Furthermore, 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. In 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.
NCT06078579
This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen.
NCT06681090
The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. The main questions it aims to answer are which is better and more effective as treatment modality. The erosion size (mm2) measured on the first day and 4 weeks later. Oral Health-Related Quality of Life questionnaire manipulated. Researchers will take Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus to see if it could be used as separate treatment option or as combination.
NCT06810752
the study aimed to assess the effect of topical application of thyme honey in comparison to 0.1% triamcinolone acetonide oral paste on the relief of pain and clinical improvement in patients with OLP
NCT04364555
The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly allocate them in three groups. The first group will receive active treatment both in the morning an evening. Group two receives placebo in the morning and active treatment in the evening. Group three will get placebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. The patients will be controlled after two weeks and and again after another two weeks. A biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. Smears for candida will also be evaluated. The patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. Our hypotheses: #Patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #Patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #The clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #A majority of the OLP lesions were infected by candida. #Specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.
NCT06697574
60 patients with clinically and histologically confirmed Oral Lichen Planus, which are are typically followed up at our oral mucosal disease clinic with a standing diagnosis for at least 1 year would be randomized. 30 would undergo a session of psychoeducation and hyponotherapy and 30 would undergo psychoeducation alone. This would be done by the PI who is an oral medicine specialist and licensed for medical hypnosis. Patients would be instructed to practice self hypnosis and would be followed up by their original oral medicine specialists who would be blinded to the intervention the had recieved - follow up would be done at 2, 6, and 12 week intervals. Patients would be asked to fill 3 standardized questionnaires (translated to Hebrew and verified): PHQ-9, OHIP-14, ERQ . The clinical appearance of their lichen planus would be documented using a standardized semi-quantitive method as described by Piboonniyom et al, OOOO 2005
NCT06550154
The goal of this observational study is to determine the prevalence of thyroid disease in adults with oral lichen planus (OLP) treated at the Dental Hospital of the University of Barcelona (HOUB), and to evaluate the association between OLP and thyroid disease. Secondly, to assess the association between OLP and other comorbidities, including arterial hypertension, diabetes mellitus type 2, dyslipidemia, anxiety, and depression. The main question it aims to answer is: Do people with OLP have a significant risk of developing thyroid disorders compared to people without OLP?
NCT06498180
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. This 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. Participants will: One 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
NCT05942794
The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.
NCT06204796
The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment