| CTRI Number |
CTRI/2025/07/091814 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing regular and laser treatments in the patient of limited mouthopening in gutkha chewers |
|
Scientific Title of Study
|
A comparative analysis of intralesional therapy and diode laser therapy in the management of oral submucous fibrosis – A split mouth approach |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTRamesh |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no-1,Block no-3,Oral Medicine and Radiology, Vishnu dental college, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9440847997 |
| Fax |
|
| Email |
ramesh.t@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTRamesh |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no-1,Block no-3,Oral Medicine and Radiology, Vishnu dental college, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9440847997 |
| Fax |
|
| Email |
ramesh.t@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Sowmya Vimala |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no-1,Block no-3,Oral Medicine and Radiology, Vishnu dental college, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7075859450 |
| Fax |
|
| Email |
nandikasowmya01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram 534202
West Godavari District, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr T Ramesh |
| Address |
Department of Oral Medicine and Radiology, Room No-1, Block-3, Vishnu Dental College, Vishnupur, Bhimavaram-534202
West Godavari District, Andhra Pradesh, INDIA |
| 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 T Ramesh |
Vishnu Dental College |
Room No 1, Oral Medicine and Radiology, Vishnu Dental College,
Vishnupur, Bhimavaram. 534202
West Godavari District, Andhra Pradesh, India
West Godavari
ANDHRA PRADESH |
9440847997
ramesh.t@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Vishnu Dental College |
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 |
Intralesional Dexamethasone and Hyaluronidase injections |
Patient will be given 15 percent w/v of lignocaine topical anaesthetic spray followed by 1cc of 1500IU Hyaluronidase and 1.5 ml of 40mg Dexamethasone on either right or left buccal mucosa for 3 minutes of duration at two or three points depending on the size of the bands twice a week for four weeks
|
| Intervention |
Laser Fibrotomy |
Patient will be given long buccal nerve block with 1 ml of 2 percent concentration lignocaine hydrochloride. Single application of Diode Laser with 980nm wavelength in continuous mode with a power of 1.5w will be applied on either right or left side of buccal mucosa till the fibers are severed completely which will be depending on the thickness of the fibrous bands and approximately for a duration of 5-10 minutes |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with bilateral palpable fibrous bands
2. patients with burning sensation
3. patients with blanching of oral mucosa
4. patients with restricted mouth opening |
|
| ExclusionCriteria |
| Details |
1. Patients who had received or undergoing treatment
2. Patients who were medically compromised
3. Patients who are not willing for treatment
4. Patients who are not willing to participate in study after the explanation of the procedure |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of pre operative and post operative mouth opening |
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Resilience of cheek
Burning sensation
Blanching of buccal mucosa |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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)
|
11/08/2025 |
| 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
|
This study is designed to
compare the intralesional injections (Dexamethasone and Hyaluronidase) and
diode lasers in the management of Oral Submucous Fibrosis patients. The
objectives of this study is to assess pre-operative and post-operative mouth
opening,cheek flexibility,burning sensation and blanching of buccal mucosa. A
total of 19 patients were included. After obtaining informed conset, flip coin method was
used to select the side of the cheek for intralesional injections ( total of 8
doses biweekly 2 doses for about 4 week will be performed ) in the middle of 2 week
after 4 dose of intralesional injection, laser fibrotomy was performed by using diode
lasers. After 4 weeks pre and postoperative assessement of out comes were
assessed. |