Comparative evaluation of the clinical applicability of CO2 laser and argon plasma coagulation therapy in the treatment of oral leukoplakia lesion-A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1 Efficacy of CO2 laser treatment and APC therapy in diagnosed oral leukoplakia.
研究概览
简要总结
Oral leukoplakia is the most common premalignant lesion of the oral mucosa and is defined as a lesion which has a white patch or plaque appearance on the oral mucosa that cannot be removed by scrapping and classified clinically or microscopically as another disease entity.The Various etiological factors for the occurrence of oral leukoplakia such as tobacco, alcohol, viral infection, candidiasis, chronic irritation associated with denture and cheek biting etc. Histopathological diagnosis criteria for leukoplakia range from simple epithelial hyperplasia with hyperkeratosis to epithelial dysplasia of variable severity. Treatment of oral leukoplakia consists of conventional surgical excision, topical and systemic medication, laser surgery, and even conservative approaches.
New technologies and improvements in surgical procedure and especially in laser surgery prove less invasive and more comfortable for patients. The use of CO2 laser is becoming increasingly common in the treatment of oral leukoplakia. Soft tissues can be superficially removed by evaporation with minimal thermal damage to adjacent tissue, which results in minimal tendency to scar and little postoperative pain and edema.
Recently Argon Plasma Coagulation (APC) Therapy, in which an argon plasma coagulator was used Argon gas is bound to the monopol.ar energy of the electric surgical apparatus where electrodes inside the applicator are supplied with a high-frequency electric current from the electrodes to the tissue via argon plasma beams, coagulating the tissue surface. According to the physical principles, argon plasma avoids already coagulated areas with high impedance on the tissue surface and flows toward non-coagulated areas with low impedance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients diagnosed with oral leukoplakia.
- •2.Patient with or without habit of tobacco consumption.
排除标准
- •1.Uncooperative patients.
- •Any active oral or peri-oral viral infections.
- •3.Any ongoing radiation therapy.
结局指标
主要结局
1 Efficacy of CO2 laser treatment and APC therapy in diagnosed oral leukoplakia.
时间窗: 10 days, 3 months, 6 months, and 12 months.
次要结局
- Recurrence rate in patient treated with CO2 laser & APC therapy in oral leukoplakia.(10 days, 3 months, 6 months, & 12 months.)
研究者
Dr SRINIVASA T.S.
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR
