Sumac Mouth Rinse in the Management of Recurrent Aphthous Stomatitis (A Randomized Controlled Clinical Study With Biochemical Assessment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pain (VAS)
研究概览
简要总结
This randomized controlled clinical study aims to evaluate the effectiveness of a Sumac mouth rinse in the management of recurrent aphthous stomatitis (RAS). In addition to assessing clinical improvement in ulcer healing and pain reduction, biochemical analysis will be performed by measuring serum TNF-α levels to evaluate the anti-inflammatory effect of Sumac.
详细描述
Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosal disorders, characterized by recurrent, painful ulcers that interfere with eating and speaking. The etiology of RAS is multifactorial and involves immune dysregulation and increased levels of inflammatory cytokines, particularly tumor necrosis factor-alpha (TNF-α).
Sumac (Rhus coriaria) is a natural herbal extract known for its anti-inflammatory, antioxidant, and antimicrobial properties. This randomized controlled clinical study aims to evaluate the clinical effectiveness of a Sumac mouth rinse in promoting ulcer healing and reducing pain among patients with recurrent aphthous stomatitis.
In addition to clinical assessment, biochemical evaluation of serum TNF-α levels will be performed before and after treatment to investigate the possible anti-inflammatory mechanism of Sumac. The study findings are expected to provide new insights into the potential therapeutic role of Sumac in managing RAS.
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, Investigator, Outcomes Assessor)
盲法说明
Both participants the outcomes assessor and the researcher were blinded to the treatment allocation. The Sumac mouth rinse and placebo were identical in appearance, color, and packaging and were stored in amber bottles to maintain blinding throughout the study.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years or older
- •Systemically healthy
- •Patients with recurrent aphthous stomatitis minor type
- •Duration of ulcer does not exceed 2 days
- •Oral pain score of 4 or higher on the Visual Analog Scale (VAS)
排除标准
- •Patients with poor oral hygiene
- •Smokers and alcohol users
- •Pregnant or lactating females
- •Patients with a history of any topical or systemic medication or steroid therapy within 1 month prior to the study
- •Vulnerable populations such as prisoners or individuals with mental or physical disabilities
研究组 & 干预措施
Study group
Study group receiving sumac mouth rinse
干预措施: Sumac mouth rinse (Other)
Control group
Control group receiving tantum Verde mouth rinse
干预措施: Tantum Verde mouth rinse (Drug)
结局指标
主要结局
Pain (VAS)
时间窗: At the baseline / Day 2 / Day 6
Visual Analog Scale (VAS) to assess the intensity of oral ulcer pain reported by the patient, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Ulcer size
时间窗: At the baseline / Day 2 / Day 6
Measurement of the oral ulcer diameter in millimeters using a ruler or photographic analysis to evaluate ulcer size reduction over time.
次要结局
- Healing index(At the baseline / Day 2/ Day 6)
- TNF- alpha(At the baseline/ Day 6)