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Clinical Trials/CTRI/2024/02/063297
CTRI/2024/02/063297Not yet recruitingPhase 4

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

Dr Vartik Shah1 site in 1 country24 target enrollmentStarted: March 11, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
1.Post-operative pain

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
15.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

1.Post-operative pain

Time Frame: On the day of surgery, first and second week post operatively

2.Post operative swelling/edema

Time Frame: On the day of surgery, first and second week post operatively

Secondary Outcomes

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

Investigators

Sponsor
Dr Vartik Shah
Sponsor Class
Other [Self Funded]
Responsible Party
Principal Investigator
Principal Investigator

Dr Vartik Shah

Government Dental College & Hospital, Nagpur

Study Sites (1)

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