View clinical trials related to Oral Leukoplakia.
Filter by: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.
Aims: To evaluate the qualitative and quantitative parameters of finger and palmar dermatoglyphic patterns in patients with oral premalignant and malignant lesions OBJECTIVES: 1. To record and study the palmar and fingerprint patterns in patients with oral premalignant and malignant lesions 2. To assess the variations in patterns of dermatoglyphic features between cases and controls and to observe the significant result. 3. To evaluate which dermatoglyphic pattern is predominant among patients with premalignant and malignant lesions. Materials and METHODS: Fingerprints and palm prints were studied in 160 patients, who were randomly divided into four groups: A. 40 patients with a history of areca nut /tobacco intake with the occurrence of the premalignant lesion (B) 40 patients with a history of areca nut /tobacco intake with the occurrence of Oral Squamous Cell Carcinoma. (C) As healthy controls, 40 patients with tobacco/areca nut chewing habits, without any evidence of oral lesions (D) 40 patients without any habit, and without any oral lesions. Dermatoglyphic patterns were recorded and analyzed in the four groups using the standard ink method.
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.
This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in > 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.
This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a). Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016). This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.
This study aims to determine the correlation between candida and pro- inflammatory cytokines response in Oral Leukoplakia(OL) with antifungal therapy. Ethical clearance from the Institutes ethical committee and Informed written consent from the patient will be obtained. The study group would comprise of clinically and histopathologically confirmed cases of OL (60 patients). The control group would be 30 dental patients ( age & sex matched) who do not any malignancy, OL or any other potentially malignant disorder of oral mucosa. Patients who have any predisposing factor for oral candidiasis will be excluded from the study. Swabs will be taken from the oral lesion and cultured for candida to determine phenotypes, virulence attributes and antifungal sensitivity. Sterile PVA opthalmic sponges will be used to collect sample from the surface of oral epithelium and then processed to determine levels of pro- inflammatory cytokines (IL-6, IL-8. IL-17, TNFα). This procedure will be repeated in study group 2 weeks after a course of antifungal therapy. The results will be tested statistically at a confidence level of 95%.
This study will be conducted to obtain data on oral cancer risk factors to generate machine learning models with good predictive accuracy for stratifying individuals with high-oral cancer risk and delineating high-risk and low-risk oral lesions. Likewise, this study will seek to provide oral cancer-related health education and training on oral-self-examination for beneficiaries
Oral leukoplakia is the most commonly occurring oral premalignant disorder. It has an overall prevalence rate of 1-4% with highest prevalence rate of 10.54% in Asian countries. The management of leukoplakia includes conventional as well as surgical modalities. The conventional approaches include Beta Carotene, Lycopene, ascorbic acid, alpha tocopherol, retinoids. But, no significant results are documented on regression rate and prevention of recurrence of the lesions. Melatonin chemically N-acetyl-5-methoxytryptamine is a hormone produced in the pineal gland. It is synthesized from the amino acid, tryptophan. The basic physiological function of melatonin is to control day night cycle and hence is commonly used in insomnia, jet lag and some other psychological disorders. Melatonin has a potent antioxidant effect and other actions such as modulation of cell cycle and induction of apoptosis, inhibition of telomerase activity, inhibition of metastasis, prevention of circadian disruption, anti-angiogenesis and stimulation of cell differentiation To date, no treatment modality has demonstrated its clear superiority for leukoplakia. There are many pathways by which melatonin can be used beneficially for management oral leukoplakia.