Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain assessment scale
研究概览
简要总结
Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus
详细描述
Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used Primary Purpose: Treatment Pain , quality of life the study on oral lichen planus, three treatment groups were established:
Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.
Group II: Was treated solely with 0.2% triamcinolone acetonide. Group III: Received only 0.1% hyaluronic acid. These groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.
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
- Double (Participant, Investigator)
盲法说明
Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.
Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient.
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
- •Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.
排除标准
- •Pregnant and lactating ladies. Patients with recent dental filling associated with the lesion or associated with recent drug administration.
- •Patient with uncontrolled diabetes, uncontrolled hypertension,
研究组 & 干预措施
Group I experimental
Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.
干预措施: Acetonide triamcinolone 0.2% +hyaluronicacid 1% (Combination Product)
Group II
Was treated exclusively with 0.2% triamcinolone acetonide.
干预措施: Corticoid Acetonide triamcinolone 0.2% (Drug)
Group III
Received only 0.1% hyaluronic acid.
干预措施: Hyaluronic acid 1% (Drug)
结局指标
主要结局
Pain assessment scale
时间窗: 4 weeks
visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.
次要结局
- OHIP-14 questionnaire(4 weeks)
- reduction of clinical signs measure(4 weeks)
- Salivary level of oxidative stress biomarker(4 weeks)
研究者
Pia Lopez Jornet
Head Oral Medicine
Universidad de Murcia