Impact of PDT and Topical Corticosteroids on Taste Perception and Salivary Oxidative Stress Markers in Patients With OLP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in taste function
研究概览
简要总结
Oral lichen planus (OLP) is a long-term inflammatory disease affecting the lining of the mouth. It may cause pain, burning sensations, discomfort, and changes in the appearance of the oral mucosa. Some patients may also notice changes in their ability to recognize different tastes.
The aim of this study is to compare two treatments used for OLP: photodynamic therapy (PDT) and topical corticosteroid therapy. PDT is a light-based treatment in which a special gel containing 5-aminolevulinic acid is applied to the affected areas and then activated using a medical light device. Topical corticosteroids are anti-inflammatory medicines applied directly to the oral lesions.
Participants are randomly assigned to receive one of these two treatments. Their ability to recognize sweet, sour, salty, and bitter tastes is assessed using special taste strips before treatment and immediately after therapy is completed. The size of the oral lesions and the severity of symptoms, such as pain and burning, are also evaluated.
Saliva samples are collected before treatment, immediately after treatment, and 3, 6, and 12 months after therapy. These samples are used to measure cortisol and several substances related to inflammation and cellular stress, including malondialdehyde, advanced oxidation protein products, peroxynitrite, nitrotyrosine, and advanced glycation end products.
The results may help researchers better understand how photodynamic therapy and topical corticosteroids affect taste perception, oral symptoms, lesion healing, and biological changes in the saliva of patients with OLP. The findings may also support the selection of the most appropriate treatment in clinical practice.
详细描述
Oral lichen planus (OLP) is a chronic inflammatory disease of the oral mucosa that is frequently associated with pain, burning sensations, and impaired quality of life. Alterations in gustatory function have also been reported in patients with OLP; however, the effects of different therapeutic approaches on taste perception and salivary biomarkers of oxidative, nitrosative, and carbonyl stress remain insufficiently investigated.
The aim of this randomized clinical trial is to evaluate and compare the effects of 5-aminolevulinic acid-based photodynamic therapy (ALA-PDT) and topical corticosteroid therapy (CT) on gustatory function, clinical outcomes, and selected salivary biomarkers in patients with clinically and histologically confirmed OLP.
Participants are randomly allocated to one of two parallel treatment groups: (1) ALA-PDT using a 5% 5-aminolevulinic acid mucoadhesive emulgel followed by irradiation with a 630 nm LED light source, administered in five weekly sessions; or (2) topical corticosteroid therapy with clobetasol propionate applied twice daily for two weeks.
Gustatory function is assessed using standardized taste strips evaluating sweet, sour, salty, and bitter taste perception, with scores ranging from 0 to 4 for each taste modality and a total taste score ranging from 0 to 16. Taste perception is evaluated before treatment initiation and immediately after completion of therapy.
Salivary concentrations of cortisol, malondialdehyde (MDA), advanced oxidation protein products (AOPP), peroxynitrite, nitrotyrosine (NT), and advanced glycation end products (AGEs) are assessed before treatment, immediately after therapy completion, and at 3, 6, and 12 months following each therapeutic intervention. These measurements are intended to evaluate longitudinal changes in psychological stress and oxidative, nitrosative, and carbonyl stress associated with OLP and its treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and laboratory personnel were blinded to group allocation. Due to the nature of the interventions (photodynamic therapy with 5-aminolevulonic acid (ALA-PDT) vs topical corticosteroids (CT)), participants and treating clinicians were not blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older
- •clinically and histologically confirmed diagnosis of oral lichen planus
排除标准
- •pregnancy or lactation presence of systemic diseases, including dermatologic diseases, oncologic diseases, or severe liver disorders known allergies use of immunomodulatory or immunosuppressive drugs use of antidepressants use of bone anti-metabolites photosensitivity allergy to the components of the photosensitizer treatment for oral lichen planus within the previous 6 months inability to attend follow-up visits presence of oral lesions other than oral lichen planus
研究组 & 干预措施
Corticosteroid therapy
Patients with clinically and histologically confirmed oral lichen planus receive topical corticosteroid therapy with clobetasol propionate cream (0.5 mg/g; Bausch Health, Poland). The medication is applied directly to the lesions twice daily for a period of two weeks, in accordance with standard clinical practice.
Gustatory function is assessed using standardized taste strips before the initiation of therapy and immediately after completion of the treatment.
干预措施: Clobetasol Propionate 0.05% Cream (Drug)
Photodynamic therapy
Patients with clinically and histologically confirmed oral lichen planus receive photodynamic therapy using a proprietary 5% 5-aminolevulinic acid (ALA) mucoadhesive emulgel (patent P.443813, Poland). After drying the oral mucosa, a 2 mm layer of the ALA emulgel is applied to the lesion and surrounding tissue twice, 40 and 20 minutes prior to irradiation. The treated area is covered with an occlusive dressing secured with gauze.
Irradiation is performed using a FotoSan® 630 LED lamp (CMS Dental, Denmark) with a wavelength of 630 nm for 6 minutes per cm² of lesion area. The treatment consists of five sessions conducted at weekly intervals.
Gustatory function is assessed using standardized taste strips before the initiation of therapy and immediately after completion of the treatment.
干预措施: 5-Amino Levulinic Acid (Drug)
结局指标
主要结局
Change in taste function
时间窗: Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group)
Change in gustatory function assessed using Taste Strips, including identification of sweet, sour, salty, and bitter tastes, and total taste score.
次要结局
- Change in pain intensity (VAS)(Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group))
- Change in lesion size(Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group))
- Change in salivary biomarkers of stress and oxidative, nitrosative, and carbonyl damage(Measurements will be performed before treatment, immediately after therapy completion, and at 3, 6, and 12 months after treatment.)
研究者
Magdalena Sulewska
Associate Professor
Medical University of Bialystok