| 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
|
|
|
Primary Sponsor
|
| Name |
Dr Srinivasa T S |
| Address |
Room no 7, AIIMS, Gorakhpur, UP |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 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
|
|
|
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. |