1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [dr.vartik@gmail.com].
   


6. For how long will this data be available start date provided 13-02-2025 and end date provided 11-03-2026?
   Response (Others) - 


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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