| CTRI Number |
CTRI/2024/12/077829 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
08/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate role of various biomarkers in diagnosis of oral submucous fibrosis |
|
Scientific Title of Study
|
Comparative evaluation of Salivary Lactate Dehydrogenase, Ferritin and Matrix Metalloproteinase-9 Biomarkers and role of expression of Programmed Death-1 and programmed Death Lignand-1 in Oral Submucous Fibrosis- A Case control 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 |
Dr kavita wadde |
| Designation |
Head of the department |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
Ranjit Deshmukh Dental College and Research Centre Nagpur
Department of Oral and Maxillofacial Surgery
Govt Dental college and hospital Mumbai
Mumbai
MAHARASHTRA
440019
India |
| Phone |
9004799405 |
| Fax |
|
| Email |
dr.kavitawadde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kavita wadde |
| Designation |
Head of the department |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
Ranjit Deshmukh Dental College and Research Centre Nagpur
Department of Oral and Maxillofacial Surgery
Govt Dental college and hospital Mumbai
Mumbai
MAHARASHTRA
440019
India |
| Phone |
9004799405 |
| Fax |
|
| Email |
dr.kavitawadde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kavita wadde |
| Designation |
Head of the department |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
Ranjit Deshmukh Dental College and Research Centre Nagpur
Department of Oral and Maxillofacial Surgery
Govt Dental college and hospital Mumbai
Mumbai
MAHARASHTRA
440019
India |
| Phone |
9004799405 |
| Fax |
|
| Email |
dr.kavitawadde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental college Mumbai
P D Mellow Road
near govt Post Office
400001 |
|
|
Primary Sponsor
|
| Name |
Dr kavita wadde |
| Address |
Government Dental College and Hospital
Department of Oral and Maxillofacial Surgery
Room No 118
Maharashtra Mumbai 400001 |
| 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 Kavita Wadde |
Government Dental College Mumbai |
Government Dental College and Hospital
Department of Oral and Maxillofacial Surgery
Room No 118
Maharashtra Mumbai 400001
Mumbai
MAHARASHTRA |
09004799405
dr.kavitawadde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL MUMBAI UNDER MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES |
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 |
group 1 healthy patients with no habit and without any systemic disease
Group 2 Healthy Patients with habit and without systemic Disease
group 3 oral submucous Fibrosis Patients
|
Salivary samples of all the group patients will be collected and comparative evaluation for salivary biomarkers will be done
before taking Incisional biopsy in OSMF role of PD-1 and PDL-2 will be evaluated once before taking biopsy |
| Intervention |
group 1 healthy patients with no habit and without any systemic disease Group 2 Healthy Patients with habit and without systemic Disease group 3 oral submucous Fibrosis Patients |
After taking Incisional Biopsy in OSMF role of PD-1 and PDL-2 will be evaluated in 3 years |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients of the age group 25-55 years were included in the study.
2. Patients consuming gutka, areca nut chewing habit.
3. Healthy patients without habit or any disease, healthy patients with habit without any
disease.
4. Patients with clinically diagnosed and histopathological confirmed Oral Submucous
Fibrosis.
5. Patients who have not received any prior treatment for Oral Submucous Fibrosis.
6. Patients without any TMJ disorders or any history of trauma.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseasesto alterserum LDH levelssuch as Myocardial Infarction,
Liver disease, Pulmonary disorders, Renal disorders and Muscle dystrophy.
2. Immunocompromised patients
3. Patients who have a habit of smoking cigarettes.
4. Patients under corticosteroid therapy
5. Patientsreceiving iron supplements.
6. Patients with other mucosal lesions other than OSMF.
7. Any Oral and Maxillofacial infections and any salivary disorders.
8. Patients who received any treatment for Oral Cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the significant role of Salivary LDH, MMP-9 and Ferritin in screening and early
detection of Oral Submucous Fibrosis and also evaluate the expression of PD-1 and PD-L1 in
Oral Submucous Fibrosis.
|
Assessment will be done at the baseline at the time of collection of samples
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It can be used as screening mass population in precancerous conditions |
assessment will be done at baseline at the time sample collection |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/12/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1. In our research, saliva is being employed as a diagnostic medium due to its non-invasive nature,
portability, and suitability for large-scale population screening.
2. The biomarkers used in the study are lactate dehydrogenase, matrix metalloproteinase-9, and ferritin
in saliva in oral submucous fibrosis. The sample collected is saliva, which is near the site of the lesion.
Their presence at the site of lesion is a sign of cellular damage and can be helpful in the early detection
and progression of the disease.
3. As oral submucous fibrosis is a potentially malignant disorder, proper patient follow-up is crucial to
prevent its progression into malignancy. Therefore, reliable biomarkers are essential for early
detection and disease progression. We are estimating the levels of biomarkers in saliva, which can be
helpful in mass screening and in determining the prognosis of the treatment given.
4. The expression of PD and PD-L1 in OPMDs may indicate a potential for malignant transformation. PD
and PD-L1 assist cells in evading immune checkpoints and promote tumor cells proliferation. Early
detection of PD and PD-L1 expression in oral submucous fibrosis can lead to a better prognosis, and
regular testing can help to monitor disease progression. This advanced method of genetic-level
detection contributes to a better understanding of the disease mechanism |