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临床试验/NCT04453215
NCT04453215已完成不适用

The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus

Dr. Merve Benli1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2019年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
1
主要终点
pain value

研究概览

简要总结

Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. The musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. The most common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been used to evaluate this treatment modality on the chewing function and pain values of SLE patients with myogenic TMD.

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 (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Having myogenic temporomandibular joint disorder,
  • •Following a stable medical regime,
  • •Showing minimum pain intensity of 50 mm on the visual analog scale.

排除标准

  • •Having concurrent systemic diseases,
  • •Using antimalarial drugs,
  • •Wearing removable prosthesis,
  • •History of facial trauma.

研究组 & 干预措施

test group

Experimental

SLE patients treated with infrared laser irradiation

干预措施: GaAlAs semiconductor diode laser device (Device)

placebo group

Placebo Comparator

SLE patients treated with red laser irradiation

干预措施: GaAlAs semiconductor diode laser device (Device)

control group

No Intervention

no therapy group

结局指标

主要结局

pain value

时间窗: 2 months

Pain intensity was evaluated by using Visual Analog Scale(VAS).

chewing function

时间窗: 2 months

The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.

次要结局

未报告次要终点

研究者

发起方
Dr. Merve Benli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Merve Benli

Assistant Professor

Istanbul University

研究点 (1)

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