Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Oral Lichen Planus : A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to provide clinical evidence on the efficacy of bromelain for managing OLP, potentially offering a safer and more effective treatment option.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from symptomatic OLP
- •Patients free from any visible oral lesions other than OLP.
- •Patients who agreed to take the supplied interventions.
- •Patient who will agree to participate in the study.
- •Patients who will accept to sign the informed consent.
排除标准
- •Patients suffering from any systemic disease.
- •Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- •Treatment with any oral topical medications for at least four weeks prior to the study.
- •Pregnant and lactating mothers.
研究组 & 干预措施
Topical Bromelain in Orabase
Participants in this group will receive topical bromelain incorporated into an orabase.
Patients will be instructed to apply the formulation four times daily No additional topical medications will be permitted.
干预措施: Topical Bromelain (Dietary Supplement)
Topical Triamcinolone Acetonide in Orabase
This group will receive topical 0.1% triamcinolone acetonide The treatment will be applied four times daily, following the same instructions and precautions as in Arm 1
干预措施: 0.1% topical triamcinolone acetonide (Drug)
Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase
Participants in this arm will be treated with a combination formulation containing both topical bromelain and 0.1% triamcinolone acetonide in orabase.
Application instructions will be identical to those in the other arms: four times daily.
干预措施: Combination of Topical Bromelain and Triamcinolone Acetonide in Orabase (Combination Product)
结局指标
主要结局
Clinical improvement
时间窗: Recorded at baseline, and weekly for 4 weeks
Clinical improvement will be measured using Thongprasom et al. scoring system. In Thongprasom et al. scale, lesions are given score as follows: 0, no lesions, normal mucosa; 1, Mild white striae, no erythematous area; 2, White striae with atrophic area \< 1 cm2; 3, White striae with atrophic area \> 1 cm2; 4, White striae with erosive area \< 1 cm2 and 5, White striae with erosive area \> 1 cm2 (Thongprasom et al., 2003).
次要结局
- Pain intensity(baseline, daily for the first week, then weekly for the remaining 3 weeks.)
- Oral health-related quality of life(at baseline, and weekly for the 4 weeks.)
研究者
Lujain Taleb Suleiman Aladwan
Master's Student in Oral Medicine
Cairo University