Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Mucosal healing
研究概览
简要总结
The primary objective of this study was to compare the therapeutic efficacy of Tacrolimus gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.
详细描述
Thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%, umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 years;
- •clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
- •presence of symptoms related to OLP.
排除标准
- •presence of systemic conditions that may have affected the study results;
- •state of pregnancy or breastfeeding;
- •histological signs of dysplasia;
- •drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.);
- •treatment of OLP in the six months prior to the start of the programme;
- •presence of extraoral lesions (genital, skin and other)
- •history of previous immunodeficiency or HIV seropositivity;
- •previous allogeneic bone marrow transplantation;
- •presence of systemic lupus erythematosus or other autoimmune diseases.
研究组 & 干预措施
Tacrolimus treatment
Apply a small amount (about 1 teaspoon) of medication to the lesions, twice a day after brushing the teeth, with a soft bristle toothbrush or with a finger (covered with a well-fitting glove).
干预措施: Oral lichen clinical Healing evaluation (Drug)
Anti-inflammatory mouthwash
Anti-inflammatory mouthwash In patients of the anti-inflammatory group, the mouthwash was used pure and without dilution at a dosage of 20 ml 3 times a day, immediately after normal daily oral hygiene was prescribed. It contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins. Patients were instructed to rinse for at least 5 minutes over the entire oral mucosa, with particular emphasis on the regions where the lesions are located.
干预措施: Oral lichen clinical Healing evaluation (Drug)
结局指标
主要结局
Clinical Mucosal healing
时间窗: 180 days
Patients clinically were evaluated using the scale used by Thongprasom et al. as reference. This gives a score that varies from 0 to 5, using a millimetre reference: 0, in the absence of lesions; 1, in the presence of hyperkeratosis streaks; 2, in the presence of an atrophic area less than 1 mm2; 3, in the presence of an atrophic area greater than 1 mm2; 4, in the presence of an erosive area less than 1 mm2; 5, in the presence of an erosive area greater than 1 mm2. In the presence of multiple injuries, the value has been calculated by summing the values of each injury.
次要结局
未报告次要终点
研究者
Gaetano Isola
Researcher
University of Catania