跳至主要内容
临床试验/CTRI/2024/06/068406
CTRI/2024/06/068406尚未招募3 期

The efficacy of Diode Laser in mouth opening and healing of Oral Submucous Fibrosis patients

Dr Sudhir Vanka1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
To study the efficacy of diode laser in mouth opening of oral submucous fibrous patients with grade 3 and grade 4a.

研究概览

简要总结

The rationale for using lasers for surgical fibrotomy in OSMF is photothermal action, resulting in tissue disruption by sufficient heat deposition to vaporize the tissue. This method is safe, effective, and minimally invasive. This study aims to understand the effectiveness of diode laser therapy in reducing symptoms, improving oral function, and preventing disease progression in OSMF patients. The study will help improve patient outcomes and contribute to the development of better treatment options for patients.

Under aseptic conditions, in all the patients the fibrous bands in the buccal mucosa will be excised with Diode LASER bilaterally. The excised regions were left raw to heal by secondary intention.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients above age of 18 years 2.Patients having OSMF with restricted mouth opening 3.Patients with Grade 3 and Grade 4a of Khanna and Andrade classification.

排除标准

  • 1.Patients with blood disorders 2.Pregnancy or lactating mothers 3.Patients with systemic complications for surgical procedure 4.Patients with history of any previous surgical procedure for the existing lesion 5.Patients with fibrosis secondary to radiation.

结局指标

主要结局

To study the efficacy of diode laser in mouth opening of oral submucous fibrous patients with grade 3 and grade 4a.

时间窗: Postoperative day 7,10,30,90,180.

次要结局

  • Improved mouth opening measured using verniercaliper(Postoperative day 7,10,30,90,180.)

研究者

发起方
Dr Sudhir Vanka
申办方类型
Other [SELF SPONSOR]
责任方
Principal Investigator
主要研究者

Dr Sudhir Vanka

KVG Dental College and Hospital

研究点 (1)

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