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临床试验/NCT06681090
NCT06681090已完成1 期

Effectiveness of Low-Level Laser Therapy and Topical Steroid Therapy in the Management of Oral Lichen Planus

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
1
主要终点
The erosion size

研究概览

简要总结

The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. The main questions it aims to answer are which is better and more effective as treatment modality. The erosion size (mm2) measured on the first day and 4 weeks later. Oral Health-Related Quality of Life questionnaire manipulated. Researchers will take Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus to see if it could be used as separate treatment option or as combination.

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 (Investigator, Outcomes Assessor)

盲法说明

Out of all the researchers, only one had knowledge of the patients' assigned groups. Neither the therapies nor their efficacy was evaluated by this unblinded researcher. There was a lack of treatment blinding for patients.

入排标准

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

入选标准

  • patients who were monitored for OLP.
  • clinical and histopathological finding of OLP in accordance with van der Meij
  • being over 18 years old.

排除标准

  • Patients with systemic disorders, pregnancy, using drugs, smoking, lesions in contact with dental amalgams, and cutaneous or other mucosal involvement at the time of treatment were excluded.

研究组 & 干预措施

Topical Steroid Therapy of Erosive oral lichen planus

Experimental

topical application of 0.1% triamcinolone acetonide and photo biomodulation on erosive oral lichen planus, 3 times daily and a miconazole oral gel once daily, for 4 weeks

干预措施: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" (Drug)

Low-Level Laser Therapy of Erosive oral lichen planus

Experimental

Photo biomodulation with laser therapy twice a week for 8 sessions over 4 weeks, utilizing a 980 nm diode laser with an output power of 300 mw.

干预措施: 980 nm diode laser (Device)

结局指标

主要结局

The erosion size

时间窗: From enrollment to the end of treatment at 4 weeks"

The maximal diameter (mm) and width (mm) were measured perpendicularly using a calibrated periodontal probe

The Visual Analogue Scale (VAS)

时间窗: From enrollment to the end of treatment at 4 weeks"

pain ratings span from zero (indicating the absence of pain) to 10 (representing extremely intense pain) along a horizontal line values. { the minimum is 0 and maximum is 10 }

次要结局

  • Oral Health-Related Quality of Life (OHRQoL)(From enrollment to the end of treatment at 4 weeks")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asem Mohammed Kamel Ali

Director

Al-Azhar University

研究点 (1)

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