Effectiveness Of Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients (A Randomized, Controlled Clinical 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
- 1
- 主要终点
- Change in severity of xerostomia
研究概览
简要总结
Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Local factors include smoking, salivary gland diseases and head and neck radiation therapy. Systemic factors include autoimmune diseases as Sjögren syndrome and hormonal disorders as Diabetes Mellitus. Photobiomodulation (PBM) previously known as Low Level Laser Therapy (LLLT) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. It also has grabbed the attention over the last few years as an effective treatment for xerostomia.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs.
- •Glycated hemoglobin less than 7%.
- •Duration of diabetes mellitus not less than 4 years and not more than 8 years
排除标准
- •Patients receiving any drugs that cause hyposalivation.
- •Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus).
- •Patients receiving chemotherapy and radiotherapy.
- •Individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure
研究组 & 干预措施
Diode laser
干预措施: Diode Laser 980 nm, 0.2W (Other)
placebo diode laser
干预措施: Placebo Diode laser (Other)
结局指标
主要结局
Change in severity of xerostomia
时间窗: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Summated Xerostomia Inventory-Dutch Version questionnaire (SXI-D) version will be used to assess the severity of xerostomia. Questions: * My mouth feels dry when eating a meal. * My mouth feels dry. * I have difficulty in eating dry foods. * I have difficulties swallowing certain foods. * My lips feel dry Scores: * Never scoring 1 * Occasionally scoring 2 * Ever scoring 3
Change in unstimulated salivary flow rate
时间窗: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Hypo-salivation will be determined if the unstimulated salivary flow rate is 0.1- 0.2 ml/min or less
Change in stimulated salivary flow rate
时间窗: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Whole-mouth SFR measurement will be conducted at every follow-up time point.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University