| 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
|
|
|
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
|
|
|
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. |