Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- change of pain from the base line to 12 weeks follow-up
研究概览
简要总结
this study evaluates the effect of diode laser in treatment of oral lichen planus.
详细描述
44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.
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
the patients were randomly assigned to avoid bios.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient histologically diagnosed with erosive OLP based on WHO modified criteria
- •Presence of painful erosive OLP lesions diagnosed by biopsy
排除标准
- •Pregnant or breast-feeding women
- •Patients currently treated for cancer with Chemotherapy or Radiotherapy
- •Patient currently on Corticosteroid therapy or had this treatment on the past 3 months
- •Those who had used Anti-inflammatory drugs topical or systemic in the last month
- •the use of drugs related to Oral Lichenoid Lesions
- •Presence of Amalgam restorations near the OLP lesions
- •dysplasia in histopathological examination
- •uncontrolled systemic diseases
- •physical or mental abnormality which would interfere with or be affected by the study procedure
- •Patients with skin lesion
研究组 & 干预措施
Kenacourt-A Orabase
the patients in this group received steroid therapy" Kenacourt-A Orabase" three times daily for 4 weeks.
antifungal drug "miconazole oral gel" once daily for 1 week
干预措施: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" (Drug)
980nm Diode Laser
the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions
干预措施: 980nm Diode Laser (Device)
结局指标
主要结局
change of pain from the base line to 12 weeks follow-up
时间窗: base line, 6weeks and 12 weeks
Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever
次要结局
- change of clinical score of the lesion from the base line to 12 weeks follow-up(base line, 6weeks and 12 weeks)