Evaluation of the Efficacy of a Mouthwash Formulation for Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial
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
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of the present research is to evaluate the efficacy of a gel formulation for a total treatment of 14 days for the treatment of traumatic or aphthous oral ulcers.
详细描述
Primary Objective
Evaluation of the clinical efficacy of the treatment using the following scores and clinical parameters:
Pain intensity, measured using the VAS (Visual Analogue Scale), consisting of a 10 cm line, where 0 indicates no pain and 10 indicates intense pain.
Size of each ulcer.
Secondary Objectives
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least one well-defined oral ulcer.
- •Patients with no cognitive disorders able to provide mouthwash treatment independently
排除标准
- •Proven intolerance or allergy to the product.
- •Patients with a hematological deficit such as anemia, iron deficiency, vitamin B12 and/or folic acid
- •No systemic diseases including ulcerative colitis, Crohn's disease, Behçet's syndrome with recurrent aphthous lesions; alcohol and tobacco consumption;
- •No history of allergies;
- •No previously treatment of oral ulcers with topical steroids, vitamins, antibiotics, antihistamines, oral retinoids, or immunomodulatory agents within three months prior to entering the study;
- •No non-steroidal anti-inflammatory drugs or mouthwash administrations for the treatment of the ulcer within 72 hours before entering the study.
- •Pregnants or breastfeeding patients.
结局指标
主要结局
Pain intensity
时间窗: 14 days
Pain intensity, measured using the VAS (Visual Analogue Scale), consisting of a 10 cm line, where 0 indicates no pain and 10 indicates intense pain.
Ulcers Dimensions
时间窗: 14 days
Size of each ulcer measured through a sheet of clear plastic will be applied directly to the ulcer by tracing the circumference of the ulcer and then placed on a graph paper and the number of mm2 units included within the drawn area will be counted.
次要结局
未报告次要终点
研究者
Felice Lorusso
Senior Researcher, Department of Innovative Technologies in Medicine and Dentistry, University "G.d'Annunzio" of Chieti-Pescara
G. d'Annunzio University