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临床试验/CTRI/2022/11/047522
CTRI/2022/11/047522已完成不适用

Management of desquamative gingival lesions of Oral Lichen Planus using Laser Patterned Microcoagulation - An Open Labeled Clinical Trial (LPM TRIAL)

MINISTRY OF DEFENCE1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月12日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Oral health quality of life

研究概览

简要总结

One of the most difficult circumstances for a periodontist is the care of problems related with desquamative gingival lesions. These individuals are typically handled with topical/systemic drugs. The introduction of LASER technology has revolutionized the management of such difficult-to-control clinical scenarios.

 Objective

 The purpose of this pilot study is to evaluate the effectiveness of a novel LASER regimen, ‘LPM PROTOCOL’ in the treatment of gingival desquamative lesions. The goals are to evaluate clinical improvement and numbers needed to treat (NNT) with topical and/or systemic steroids.

 Methodology

 Ten patients  with chronic desquamative gingivitis related to Oral Lichen Planus will be treated with LPM PROTOCOL. Treatment will be delivered in four sittings and followed for 06 months. All the clinical parameters will be recorded at baseline, 03 months, 06 months.

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
19.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with oral lichen planus Presenting with desquamative gingival lesions alone Not on any other topical or systemic medication for the same Systemically no other comorbid conditions.

排除标准

  • Patients exhibiting dermatologic manifestations Unwilling for laser therapy Pregnancy Lactation Recent history of steroid use within 6 months.

结局指标

主要结局

Oral health quality of life

时间窗: Baseline, 03 months, 06 months

Numerical rating scale for pain

时间窗: Baseline, 03 months, 06 months

Photometric reduction of desquamated areas

时间窗: Baseline, 03 months, 06 months

次要结局

  • Number needed to treat with topical or systemic steroids(Baseline, 03 months and 06 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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