Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis
详细描述
Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.
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 (Care Provider, Outcomes Assessor)
盲法说明
The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were as follows:
- •Age 18-30 years.
- •Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.
排除标准
- •known history of hypersensitivities to Chlorhexidine or hyaluronic acid.
- •Use of any medication as a treatment for the present active ulcer.
- •Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease.
- •Pregnant or breast-feeding women.
- •Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus.
- •Treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or other immune modulatory agents, oral antihistamines, or systemic antibiotics in the previous 3 months.
研究组 & 干预措施
Control group
Topical cholrhexidine hydrochloride 125 mg/100 ml available commercially (Hexitol; Arab Drug Company for Pharmaceutical and Chemical Industries, Cairo, Egypt) mouthwash. Topical cholrhexidine hydrochloride mouthwash treatment has been repeated three times per day for one week.
干预措施: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Drug)
Hyaluronic acid group (HA group)
Topical hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Aftamed; Bioplaxpharma, UK).Topical hyaluronic acid mouthwash treatment has been repeated three times per day for one week.
干预措施: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Drug)
结局指标
主要结局
Pain score
时间窗: one week
Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome) after irritation of the ulcer with the periodontal probe.
次要结局
- Ulcer size(one week)
- Duration of healing(one week)
研究者
Mai Zakaria Ibrahium Mohammed
Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt
Cairo University