Active Control,Randomized,Double- Blinded Clinical Trial of BD
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 主要终点
- Oral ulcer activity index
研究概览
简要总结
Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.
详细描述
The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.
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, Investigator)
盲法说明
Double - blinded trial:
Outcome assessor (CS) and Statistician. Participants couldn't be blinded because of the difference in the nature of interventions method of application.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with Behcet's Disease according to International Criteria for BD.
- •patients with active oral ulcers.
- •patients free from any visible oral lesions other than the oral ulcers of BD.
- •patients who agreed to take the supplied interventions.
- •patients who will agree to participate in the study.
- •patients who will accept to sign the informed consent.
排除标准
- •patients not physically able to participate in survey or clinical oral examination.
- •patients with organ or life-threatening disease.
- •patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus.
- •patients under immunosuppressive drugs.
- •patients with organ transplantation.
研究组 & 干预措施
Triamcinolone acetonide
Triamcinolone acetonide 0.1% 5 gm adhesive paste 4 times / day for 1 month.
干预措施: Triamcinolone Acetonide (Drug)
Diode laser
Diode laser 980 nm & 100mWatt.
干预措施: Diode laser 980nm&100 mWatt (Radiation)
结局指标
主要结局
Oral ulcer activity index
时间窗: One month
Composite index score (0-10)
次要结局
- Pain associated with oral ulcer(One month)
- Oral health - related quality of life(One month)
研究者
Clair Sobhy Nagieb Botros
Principal invistigator
Cairo University