跳至主要内容
临床试验/CTRI/2024/02/063297
CTRI/2024/02/063297尚未招募4 期

Comparative evaluation of CO2 Laser and traditional scalpel in the surgical management of oral potentially malignant disorder- A Randomized Controlled Trial

Dr Vartik Shah1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年3月11日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
1.Post-operative pain

研究概览

简要总结

Oral Potentially Malignant Diseases, abbreviated as OPMD, is a term used to describe a number of oral mucosal conditions that have a higher chance of developing cancer. Oral leukoplakia, erythroplakia, erythroleukoplakia, oral submucous fibrosis (OSF), palatal lesions in reverse smokers, and oral lichen planus are among the variety of OPMDs. Surgical removal of the lesion (cold-knife, laser excision and vaporization, cryosurgery, photodynamic therapy), medical treatment(topical or systemic), cessation of risk activities and surveillance has been the standard care of these lesions

CO2 laser was invented in 1964 by Kumar Patel. Since the 1970s, CO2 laser therapy has demonstrated to be a successful means of treating patients with a variety of oral lesions. When combined with diligent clinical follow-up, patient education to reduce risk factors, and reporting and biopsying of any suspicious lesions, laser surgery for oral premalignant disease has shown to be an efficient treatment option.

CO2 laser is considered to be the ideal laser and is very useful in oral surgical procedures since the energy is maximally absorbed by water in oral tissues. Cellular vaporisation occurs due to photothermal effect which is the basis for tissue cutting by CO2 laser. The heat generated by the laser raises the temperature within the target tissues above 100 ° C, which results in the conversion of water into steam. As this causes instantaneous vaporisation of intracellular fluid, it is thought that it may prevent the release of chemical mediators of inflammation, and thereby reducing the acute inflammatory response. A virtually bloodless field is created as blood vessels with a lumen of less than 0.5 mm are sealed off with the laser

In comparison to scalpels, laser surgery has been found to have a number of benefits. These benefits include less post-operative pain, less scarring, and haemostasis. It also has the benefits of minimally affecting nearby tissue, delaying the immediate inflammatory response, and reducing myofibroblast activity, which reduces wound contraction and scarring. The reduction in collagen production in post-operative phase maintains soft tissue movement. It is also possible to leave the laser-treated region exposed to granulate without the requirement for skin grafting or wound dressing. It is also hypothesised that laser surgery causes less post-operative discomfort

This study is planned in the department of oral and maxillofacial surgery to assess and compare ease of operability and healing outcomes on the day of surgery, first and second week post operatively following excision of OPMDs with CO2 laser when compared to excision done with a scalpel and evaluating on the basis of intraoperative time , intraoperative bleeding and post-operative pain, swelling and scarring

PRIMARY RESEARCH QUESTION:

Whether CO2 Laser is a valuable tool and better alternative to traditional scalpel for surgical management of Oral Potentially Malignant Diseases

Primary Hypothesis- There is no statistically significant difference in intraoperative bleeding, ease of operability and post-operative pain, swelling and scarring between CO2 lasers and traditional scalpel when used for surgical management of Oral Potentially Malignant Diseases

Alternate Hypothesis-There is statistically significant difference in intraoperative bleeding, ease of operability and post-operative pain, swelling and scarring between CO2 lasers and traditional scalpel when used for surgical management of Oral Potentially Malignant Diseases

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • All the patients reporting to department with oral potentially malignant disorders
  • Patients of age 15 years and above and below 75 years
  • Patients fit to undergo surgical excision under necessary anaesthesia
  • Patients with controlled blood sugar level
  • Patients with good general health status.

排除标准

  • Patients with systemic immunocompromised conditions
  • Patients who are pregnant/ lactating mothers
  • Patients not fit to undergo surgical excision under necessary anaesthesia
  • Patients not willing to be a part of the study.

结局指标

主要结局

1.Post-operative pain

时间窗: On the day of surgery, first and second week post operatively

2.Post operative swelling/edema

时间窗: On the day of surgery, first and second week post operatively

次要结局

  • Ease of operability(On the day of surgery)
  • Intraoperative bleeding(On the day of surgery)
  • Post-operative scarring(First and second week post operatively)

研究者

发起方
Dr Vartik Shah
申办方类型
Other [Self Funded]
责任方
Principal Investigator
主要研究者

Dr Vartik Shah

Government Dental College & Hospital, Nagpur

研究点 (1)

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