| CTRI Number |
CTRI/2024/02/062349 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study To Know The Productiveness Of Diode Laser In Treatment Of Oral Leukoplakia |
|
Scientific Title of Study
|
Study To Assess Effectiveness Of Diode Laser In Treatment Of Oral Leukoplakia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darsi Aditya |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room Number - 1
Department of Oral Medicine and Radiology,
Narayana Dental College And Hospital, Chintareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9603752411 |
| Fax |
|
| Email |
darsiaditya786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Kannan |
| Designation |
Professor and Head of Department |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room Number - 1
Department of Oral Medicine and Radiology
Narayana Dental College and Hospital, Chintareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490471078 |
| Fax |
|
| Email |
dentkan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Darsi Aditya |
| Designation |
post Graduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room Number - 1
Department of Oral Medicine and Radiology,
Narayana Dental College And Hospital Chintareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9603752411 |
| Fax |
|
| Email |
darsiaditya786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Darsi Aditya |
| Address |
Narayana Dental College And Hospital, Chintareddypalem, Nellore, 524003 |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
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 Darsi Aditya |
Narayana Dental College and Hospital |
Room No:-1
Department of Oral Medicine and Radiology
Nellore
ANDHRA PRADESH |
9603752411
darsiaditya786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NARAYANA DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode Laser |
Duration of Therapy: Lesion is removed at the time of treatment and patient is follow up for 3 months to check the recurrence of the lesion |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients present with clinical features of oral
Leukoplakia
2 Patients willing to participate in the study
3 Patients willing to give up tobacco habits |
|
| ExclusionCriteria |
| Details |
1 Patients not willing for participation
2 Clinical evidence of Malignancy
3 Patients with Photo phobia
4 Patients not willing to give up tobacco habits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the effectiveness of Diode Laser in 25 patients |
3rd day, End of 1st week, 2nd week and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the recurrence of Leukoplakia after removing with Diode laser |
3rd day, End of 1st week, 2nd week & 3rd month |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 4 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Patients visting OPD of Narayana dental college and hospital, diagnosed with Oral Leukoplakia will be treated with diode laser. Patient reviewed upto 3 months to check the effectiveness of diode laser and also to check the recurrence of oral leukoplakia. |