| CTRI Number |
CTRI/2024/06/068406 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Success rate of Diode Laser in treating Oral Submucous Fibrosis |
|
Scientific Title of Study
|
The efficacy of Diode Laser in mouth opening and healing of Oral Submucous Fibrosis patients |
| 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 Sudhir Vanka |
| Designation |
Post Graduate Student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room No 2
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital
Kurunjibhag
Sullia
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8880085266 |
| Fax |
|
| Email |
sudhirvanka3444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Kumar D |
| Designation |
Professor and Head of Department |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room No 2
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital
Kurunjibhag
Sullia
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448177525 |
| Fax |
|
| Email |
dr_prasanna_74@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Kumar D |
| Designation |
Professor and Head of Department |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room No 2
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital
Kurunjibhag
Sullia
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448177525 |
| Fax |
|
| Email |
dr_prasanna_74@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital
Kurunjibhag
Sullia D K
Karnataka
Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Sudhir Vanka |
| Address |
KVG Dental College and Hospital
Kurunjibhag
Sullia
Dakshina Kannada
Karnataka
Pincode 574327 |
| Type of Sponsor |
Other [SELF SPONSOR] |
|
|
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 Sudhir Vanka |
KVG Dental College and Hospital |
Room No 2
Department of Oral and Maxillofacial Surgery
KVG Dental College and Hospital
Kurunjibhag
Sullia
Dakshina Kannada
Karnataka
Pincode 574327
Dakshina Kannada
KARNATAKA |
8880085266
sudhirvanka3444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Surgical removal OSMF bands using diode laser |
940nm Diode laser is used in removing the fibrous bands in osmf patients.
Duration of the procedure is 30 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above age of 18 years
2.Patients having OSMF with restricted mouth opening
3.Patients with Grade 3 and Grade 4a of Khanna and Andrade classification |
|
| ExclusionCriteria |
| Details |
1.Patients with blood disorders
2.Pregnancy or lactating mothers
3.Patients with systemic complications for surgical procedure
4.Patients with history of any previous surgical procedure for the existing lesion
5.Patients with fibrosis secondary to radiation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of diode laser in mouth opening of oral submucous fibrous patients with grade 3 and grade 4a. |
Postoperative day 7,10,30,90,180. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved mouth opening measured using verniercaliper |
Postoperative day 7,10,30,90,180. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
17/06/2024 |
| 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="2"
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
|
The rationale for using lasers for surgical fibrotomy in OSMF is photothermal action, resulting in tissue disruption by sufficient heat deposition to vaporize the tissue. This method is safe, effective, and minimally invasive. This study aims to understand the effectiveness of diode laser therapy in reducing symptoms, improving oral function, and preventing disease progression in OSMF patients. The study will help improve patient outcomes and contribute to the development of better treatment options for patients.
Under aseptic conditions, in all the patients the fibrous bands in the buccal mucosa will be excised with Diode LASER bilaterally. The excised regions were left raw to heal by secondary intention. |