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CTRI Number  CTRI/2025/02/080743 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Other (Specify) [CO2 LASER Excision]  
Study Design  Other 
Public Title of Study   Using CO2 LASER for oral and lip lesions 
Scientific Title of Study   Clinical outcome of CO2 LASER Excision of various types of Oral and Lip lesions. 
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 Shuklima Sengupta 
Designation  Post Graduate Trainee 
Affiliation  Silchar Medical College and Hospital 
Address  Department of Otorhinolaryngology Silchar Medical College and Hospital ghungoor Silchar 788014

Cachar
ASSAM
788014
India 
Phone  7044284004  
Fax    
Email  sengupta.shuklima27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smrity Rupa Borah Dutta 
Designation  Professor & Head of the Department 
Affiliation  Silchar Medical College and Hospital 
Address  Department of Otorhinolaryngology Silchar Medical College and Hospital ghungoor Silchar 788014

Cachar
ASSAM
788014
India 
Phone  9435348294  
Fax    
Email  smritylana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smrity Rupa Borah Dutta 
Designation  Professor & Head of the Department 
Affiliation  Silchar Medical College and Hospital 
Address  Department of Otorhinolaryngology Silchar Medical College and Hospital ghungoor Silchar 788014

Cachar
ASSAM
788014
India 
Phone  9435348294  
Fax    
Email  smritylana@gmail.com  
 
Source of Monetary or Material Support  
Silchar Medical College and Hospital,Silchar , Ghungoor, Cachar District, Pin 788014, Assam, India. 
 
Primary Sponsor  
Name  Dr Shuklima Sengupta 
Address  Department of Otorhinolaryngology Silchar Medical College and Hospital ghungoor Silchar 788014 
Type of Sponsor  Other [Self] 
 
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 Shuklima Sengupta  Silchar Medical College and Hospital  Department of Otorhinolaryngology Silchar Medical College and Hospital ghungoor Silchar 788014
Cachar
ASSAM 
7044284004

sengupta.shuklima27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D100||Benign neoplasm of lip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Co2 Laser excision  Co2 laser surgery used to excise oral lesions 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  all patients above 12years with oral lesions like tongue tie, mucoceles, papilloma, fibroma, erythoplakia, leukoplakia etc 
 
ExclusionCriteria 
Details  patients below 12years.
patients with extensive disease with cervical lymphadenopathies requiring exploration of other anatomical sites than primary. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assesment during surgery and post surgery with respect to pain, hemorrhage, scaring, edema, healing time, suturing.  Day 1 and
After 1month 
 
Secondary Outcome  
Outcome  TimePoints 
HPE of the specimen from lesion.
Recurrence 
1month post surgery 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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   N/A 
Date of First Enrollment (India)   26/02/2025 
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 Yet Recruiting 
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  
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.
 
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