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临床试验/CTRI/2025/02/080743
CTRI/2025/02/080743尚未招募不适用

Clinical outcome of CO2 LASER Excision of various types of Oral and Lip lesions.

Dr Shuklima Sengupta1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年2月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
Assesment during surgery and post surgery with respect to pain, hemorrhage, scaring, edema, healing time, suturing.

研究概览

简要总结

LASER meaning Light Amplification by Stimulated Emission of Radiation, has been in use for more than a decade. Carbon dioxide (CO2) laser was the 1st type that was used in medical treatments. Producing beams of light at a 10,600nm wavelength which, are absorbed by water in tissues, causes hemostasis, allowing excision of large variety of soft tissue lesions.

Thus, Laser has become more favourable and is recomended to treat benign OLs, such as fibroma, vascular anomalies, mucoceles, gingival hyperplasia, mucosal frenulas, tongue ties, pre malignant lesion like oral leukoplakia, erythroplakia, papilloma, malignant conditions like mucosal melanoma.

Laser excision is very precise and accurate. By adjusting the time, power of exposure of Laser, depth of excision can be kept under control. Biological and clinical studies have shown that wounds produced by the C02 laser highly differs from that of scalpel.

At first a coagulum of denatured protein forms on the surface while using Laser and minimal injury occurs at surrounding tissues, thus Dressing is not required and the area should be kept exposed for secondary healing. There is delayed inflammatory reaction and a few myofibroblasts at the base of the wound thus little contraction occurs following excision by laser.

Other conventional techniques for excision of oral lesions have limitations because of highly vascular oral mucosa and limited exposure. With scalpel use, there is increased chances of bleeding causing difficulty identifying tumour margins, increased post operative edema, increased risk for bacterial contamination of the site with poorly sterilised scalpel, also more thermal damage to nearby area while using diathermy causing inadequate histopathological assessment of the margins of the specimen.

The use of CO2 laser hence is advantageous with less amount of post operative pain and edema. The tissue margins can be preserved and bacterial contamination of the site can be reduced.

AIMS AND OBJECTIVES :

Primary objective :

1.To assess the efficacy of CO2 Laser in excision of oral lesions.

Secondary objective:

2.To assess the prevalence of various types of oral lesions attending Out patient Department of Otorhinolaryngology, Silchar Medical College & Hospital.

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
12.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • all patients above 12years with oral lesions like tongue tie, mucoceles, papilloma, fibroma, erythoplakia, leukoplakia etc.

排除标准

  • patients below 12years.
  • patients with extensive disease with cervical lymphadenopathies requiring exploration of other anatomical sites than primary.

结局指标

主要结局

Assesment during surgery and post surgery with respect to pain, hemorrhage, scaring, edema, healing time, suturing.

时间窗: Day 1 and | After 1month

次要结局

  • HPE of the specimen from lesion.(Recurrence)

研究者

发起方
Dr Shuklima Sengupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shuklima Sengupta

Silchar Medical College and Hospital

研究点 (1)

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