| CTRI Number |
CTRI/2024/10/075771 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative analysis between Standard scalpel fibrotomy and Laser fibrotomy in patients with Bilateral oral submucous fibrosis
|
|
Scientific Title of Study
|
Comparision of Conventional scalpel fibrotomy versus Diode laser fibrotomy in Oral submucous fibrosis
- A Prospective study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaya Aishwariyagha S |
| Designation |
Post Graduate trainee |
| Affiliation |
Thai moogambigai dental college |
| Address |
Branch 3, Department of Oral and maxillofacial surgery, Thai Moogambigai dental college and hospital, Golden george nagar, Mogappair
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
7358442341 |
| Fax |
|
| Email |
jayaaishwariyagha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Senthil kumar K |
| Designation |
Professor |
| Affiliation |
Thai moogambigai dental college |
| Address |
Branch 3, Department of Oral and maxillofacial surgery, Thai Moogambigai dental college and hospital, Golden george nagar, Mogappair
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
9884634754 |
| Fax |
|
| Email |
senthilomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Senthil kumar K |
| Designation |
Professor |
| Affiliation |
Thai moogambigai dental college |
| Address |
Branch 3, Department of Oral and maxillofacial surgery, Thai Moogambigai dental college and hospital, Golden george nagar, Mogappair
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
9884634754 |
| Fax |
|
| Email |
senthilomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.M.G.R Educational and research institute, Thai Moogambigai dental college and hospital, Branch no.3,Department of Oral and maxillofacial surgery,Golden george nagar,Mogappair, Chennai-600107 |
|
|
Primary Sponsor
|
| Name |
Jaya Aishwariyagha S |
| Address |
Branch 3, Department of Oral and maxillofacial surgery, Thai moogambigai dental college and hospital, Golden george nagar, Mogappair, Thiruvallur,600107 |
| 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 |
| DrJaya Aishwariyagha S |
Thai Moogambigai dental college and hospital |
Branch 03,Department of oral and maxillofacial surgery, Golden george nagar,Mugappair,Chennai, Pincode-600107
Thiruvallur
TAMIL NADU |
7358442341
jayaaishwariyagha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF THAI MOOGAMBIGAI 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 |
Diode laser |
Inverted Y shaped release of fibrous bands done bilaterally using diode laser of 980nm wavelength at 2.5Watts in a single sitting.
Follow up is done for 6 months. |
| Intervention |
Scalpel blade |
Inverted Y shaped release of fibrous bands done bilaterally using Bard parker number 15 blade in a single sitting. Follow up is done for 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Limited mouth opening of 26-35mm and 15-25mm: Khanna JN and Andrade classification
Patient who already underwent intralesional therapy |
|
| ExclusionCriteria |
| Details |
Patient who are unable to stop the habit.
Medically compromised and uncooperative patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Mouth opening following fibrotomy |
6 months follow up- post op 1st day,3rd day,7 th day and on 1st,3rd and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess healing,pain,swelling and compare between two groups. |
Follow up - Post op 1st day,3rd day,7 th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Title - Comparision of Conventional Scalpel Fibrotomy versus Diode laser fibrotomy in oral submucous fibrosis - A Prospective study
Age: No age limit Gender: No gender prediliction
Inclusion criteria: Mouth opening of 26-35mm(stage 2) and 15-25mm(stage3) - Khanna JN and Andrade classification Exclusion criteria: Patient who cannot stop the habit; Uncooperative and medically compromised patients
Methods: Group A- Surgical blade fibrotomy (10 patients) Group B- Diode laser fibrotomy (10 patients)
Follow up: 6 months
|