Comparative evaluation of Therapeutic effects of diode laser with curcumin and diode laser without curcumin in the management of homogenous type of oral leukoplakia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the pain score, size of the lesion & healing index in patients treating diode laser with curcumin in oral leukoplakia patients
研究概览
简要总结
•Oral cancer is the sixth most common cancer worldwide.
•Oral cancer leaded by noticeable clinical changes in the form of white or red patches in oral mucosa & set forth the theory of two-step process of cancer development.
•The changes in oral cavity are labelled as “potentially malignant disorders (PMD) of oral cavity .
•Presently, it has multiple treatment modalities such as surgical and conservative methods. The commonly used conservative modalities are antifungal ointments, glycerine soap massage, vitamin A supplements, Antioxidants
•Recently lasers have also been tried as a treatment modality for PMD & amazing results were proved.
•Diode laser is commonly used as a surgical soft tissue laser for the complete excision of the lesion, which provides promising results without any complication & without compromising health and function of the patients.
•With the advancement in the field of medicine, antioxidants have gained a lot of importance because of their potential as prophylactic and therapeutic agents in potentially malignant disorders.
•They have anti-inflammatory, analgesic, antioxidant and anticancer properties and have been found to constrain many disease process
•Recently lasers have also been tried as a treatment modality for PMD & amazing results were proved.
•Diode laser is commonly used as a surgical soft tissue laser for the complete excision of the lesion, which provides promising results without any complication & without compromising health and function of the patients.
•With the advancement in the field of medicine, antioxidants have gained a lot of importance because of their potential as prophylactic and therapeutic agents in potentially malignant disorders.
•They have anti-inflammatory, analgesic, antioxidant and anticancer properties and have been found to constrain many disease process
AIM
To evaluate the effects of diode laser with curcumin as an adjuvant in treating oral leukoplakia.
OBJECTIVES:
•To determine the effectiveness of the diode laser with curcumin as an adjuvant and without curcumin in treating oral leukoplakia.
•To assess the pain score, size of the lesion, healing index, recurrence of the lesion and malignant transformation.
OUTCOME
• The outcomes assessed were a change in the pain score, a change in the burning sensation score, a change in the size of the lesion, complete clinical resolution of the lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group- 30- 75 years Both males and females Patients with homogenous type of leukoplakia Patients who are ready to quit the habit- smoking, tobacco & alcohol habits Patients who had not taken any treatment earlier for leukoplakia Â.
排除标准
- •Patients on topical corticosteroids Patients with chronic debilitating disease Patients with non-homogenous type of leukoplakia Lesions on the tongue and floor of mouth Pregnancy and lactating mothers Patients with other mucosal lesions like oral submucous fibrosis, malignant lesions Patients who are already diagnosed as cancer patients History of hypersensitivity to curcumin.
结局指标
主要结局
To assess the pain score, size of the lesion & healing index in patients treating diode laser with curcumin in oral leukoplakia patients
时间窗: two months
To assess the pain score, size of the lesion & healing index in patients treating diode laser without curcumin in oral leukoplakia patients
时间窗: two months
To compare the pain score, size of lesion, healing index in both groups.
时间窗: two months
次要结局
- To assess the recurrence of lesion & malignant transformation in both the groups(two months)