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CTRI Number  CTRI/2025/01/079486 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of CO2 Laser and Argon Plasma Coagulation Therapy in the Treatment of Oral Leukoplakia 
Scientific Title of Study   Comparative evaluation of the clinical applicability of CO2 laser and argon plasma coagulation therapy in the treatment of oral leukoplakia lesion-A randomized controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SRINIVASA T.S. 
Designation  Professor & HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
Address  ROOM NO 7, DEPT OF DENTISTRY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KUNRAGHAT.
KUNRAGHAT
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9993519183  
Fax    
Email  seen79@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SRINIVASA T.S. 
Designation  Professor & HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
Address  Room no 7, Dept of Dentistry, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KUNRAGHAT.
KUNRAGHAT.
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9993519183  
Fax    
Email  seen79@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SRINIVASA T S 
Designation  Professor & HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
Address  ROOM NO 7, Dept of Dentistry, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, KUNRAGHAT.
KUNRAGHAT.
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9993519183  
Fax    
Email  seen79@rediffmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Dr Srinivasa T S 
Address  Room no 7, AIIMS, Gorakhpur, UP 
Type of Sponsor  Other [SELF FUNDED] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SRINIVASA TS  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR   Dept. of Dentistry & Dept of Dermatology and Venereology
Gorakhpur
UTTAR PRADESH 
9993519183

seen79@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE AIIMS GORAKHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Argon Coagulation Therapy  Procedure: Patient will be asked to perform a preoperative rinse with 0.2% chlorhexidine as an antiseptic measure. Administration of local anesthesia at the site of the lesion. Patient’s eyes will be covered with protective eye pads. Coagulation will be performed at an argon flow rate of 1.0 to 1.4 l/minute at 20 to 30 W using the probe in a stroking manner 3 mm away from the tissue surface. A safety zone of approximately 3 mm from the lesion will be established for the coagulation area. After surgery, gauze impregnated with 0.2% chlorhexidine will be applied to the wound for 20 min. 
Intervention  CO2 laser Therapy  Procedure: Patient will be asked to perform a preoperative rinse with 0.2% chlorhexidine as an antiseptic measure. Administration of local anesthesia at the site of the lesion. Patient’s eyes will be covered with protective eye pads. CO2 laser will be used in continuous mode at a distance of 0.5 to 1cm from the oral mucosa and at intervals of approximately 5-10 sec. Lesion will be eliminated with the laser using vertical and horizontal movements, including approximately 3mm of clinically normal mucosa at periphery. After surgery, gauze impregnated with 0.2% chlorhexidine will be applied to the wound for 20 min. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with oral leukoplakia.
2.Patient with or without habit of tobacco consumption.
 
 
ExclusionCriteria 
Details  1.Uncooperative patients.
2. Any active oral or peri-oral viral infections.
3.Any ongoing radiation therapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Efficacy of CO2 laser treatment and APC therapy in diagnosed oral leukoplakia.
 
10 days, 3 months, 6 months, and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence rate in patient treated with CO2 laser & APC therapy in oral leukoplakia.  10 days, 3 months, 6 months, & 12 months. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Oral leukoplakia is the most common premalignant lesion of the oral mucosa and is defined as a lesion which has a white patch or plaque appearance on the oral mucosa that cannot be removed by scrapping and classified clinically or microscopically as another disease entity. The Various etiological factors for the occurrence of oral leukoplakia such as tobacco, alcohol, viral infection, candidiasis, chronic irritation associated with denture and cheek biting etc. Histopathological diagnosis criteria for leukoplakia range from simple epithelial hyperplasia with hyperkeratosis to epithelial dysplasia of variable severity. Treatment of oral leukoplakia consists of conventional surgical excision, topical and systemic medication, laser surgery, and even conservative approaches.

New technologies and improvements in surgical procedure and especially in laser surgery prove less invasive and more comfortable for patients. The use of CO2 laser is becoming increasingly common in the treatment of oral leukoplakia. Soft tissues can be superficially removed by evaporation with minimal thermal damage to adjacent tissue, which results in minimal tendency to scar and little postoperative pain and edema

Recently Argon Plasma Coagulation (APC) Therapy, in which an argon plasma coagulator was used Argon gas is bound to the monopol.ar energy of the electric surgical apparatus where electrodes inside the applicator are supplied with a high-frequency electric current from the electrodes to the tissue via argon plasma beams, coagulating the tissue surface. According to the physical principles, argon plasma avoids already coagulated areas with high impedance on the tissue surface and flows toward non-coagulated areas with low impedance. 
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