Treatment of Aphtous Ulcers With Photodynamic Therapy: A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Ulcer wound healing with diameter measurement
研究概览
简要总结
The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers.
详细描述
After sample size calculation, photodynamic therapy and control groups were formed with 15 patients with aphthous ulcer in each group. Laser therapy with indocyanine green was applied to the photodynamic therapy group on the day they were admitted to the clinic. No treatment was performed in the control group and only follow-up was performed. Lesion diameters, pain intensity and degree of improvement at the end of 1 week were recorded in all patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA-1 patients without any systemic disease,
- •With a history of canker sores not exceeding 2 days,
- •Not taking any antibiotics or anti-inflammatory drugs.
排除标准
- •Laser therapy contraindicated,
- •Pregnancy,
- •Smoking habbit,
- •Poor oral hygiene,
- •Patients under 18 years of age
结局指标
主要结局
Ulcer wound healing with diameter measurement
时间窗: One week (preoperatively and on postoperative days 3, 5 and 7 )
Lesion diameters were measured with a elastic ruler and the healing rate of the lesion was monitored.
Level of recovery
时间窗: Postoperatively 7 th day
A 3-point scale was used. Grade 1 represents "complete recovery", Grade 2 represents "moderate recovery", Grade 3 represents "little recovery".
次要结局
- Pain evaluation with Visual Analogue Scale(One week)
研究者
Cennet Neslihan Eroglu
Assoc Prof Dr
Yuzuncu Yil University