| CTRI Number |
CTRI/2025/08/092173 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Injection Treatments for Patients with Oral Submucous Fibrosis (OSMF): Dexamethasone with Hyaluronidase vs Platelet-Rich Plasma (PRP), and Their Effects on Mouth Opening and Symptoms |
|
Scientific Title of Study
|
Comparative evaluation of Injection dexamethasone with Hyaluronidase and Injection Platelet Rich Plasma (PRP) in Management of Oral Submucous Fibrosis (OSMF)- A randomized controlled trial. |
| 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 Sneha Sarang |
| Designation |
Post graduate student |
| Affiliation |
Sinhgad dental college and hospital, Pune |
| Address |
Department of oral medicine and radiology (2A), ground floor, sinhgad dental college and hospital, vadgaon bk, pune
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
8999536588 |
| Fax |
|
| Email |
snehaaasarang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Chavan |
| Designation |
Guide |
| Affiliation |
Professor and head of department |
| Address |
Department of oral medicine and radiology (2A), ground floor, Sinhgad dental college and hospital, vadgaon bk, Pune
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9823623445 |
| Fax |
|
| Email |
drmaheshschavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Sarang |
| Designation |
Post graduate student |
| Affiliation |
Sinhgad dental college and hospital, Pune |
| Address |
Department of oral medicine and radiology (2A), ground floor, Sinhgad dental college and hospital, vadgaon bk, Pune
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
8999536588 |
| Fax |
|
| Email |
snehaaasarang@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sneha Sarang |
| Address |
Department of oral medicine and radiology (2A), ground floor, Sinhgad dental college and hospital, vadgaon bk, Pune
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 |
| 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 Sneha Sarang |
Sinhgad dental college and hospital, Pune |
Department of oral medicine and radiology (2A), ground floor, Sinhgad dental college and hospital, vadgaon bk, Pune
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA |
08999536588
snehaaasarang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, (2) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection dexamethasone with Hyaluronidase |
All the patients in this group will receive weekly injections of dexamethasone (1.5mg) and hyaluronidase (1500 I U) mixed with 2% lignocaine hydrochloride (1:80,000) for 6 weeks
Injections will be given by insulin syringe after applying topical anesthesia in the affected area
The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.
|
| Intervention |
Platelet rich plasma |
Patients of intervention group will be given freshly prepared Platelet rich plasma from their own blood sample, for that blood sample of 10 ml will be withdrawn and collected in plain tube to process it in centrifugation machine for 5 min on 1000rpm and then 15 min on 3000rpm,then obtained plasma will be injected by insuline syringe on affected site after applying topical anesthesia.
All the patients in this group will receive weekly injections of freshly prepared PRP from their own blood samples for 6 weeks.
A 10-12 cc venous blood draw will yield 2-3 cc of PRP depending on the baseline platelet count of an individual
The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with age greater than 18 years and of either gender
2) Individuals with clinically diagnosed oral submucous fibrosis in stages I II and III (according to the classification of Nagesh and Bailoor 1993)
3) Patients who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1) Patients who did not give consent for participation.
2) Patients in which steroids are contraindicated.
3) Patients with systemic disorders. (Patients on anticoagulant therapy diabetes mellitus hypertension bronchitis)
4) Patients with severely reduced mouth-opening
5) Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Triamcinolone acetonide with hyaluronidase injection versus Platelet rich plasma injection in OSMF patients in parameters as 1.Mouth opening (Inter-incisal distance IID)
2.Burning sensation and pain
3.cheek flexibility |
The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
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="2"
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
|
Oral submucous fibrosis (OSMF) is a potentially malignant condition of the oral cavity resulting in increasing loss of tissue mobility, marked rigidity, and eventual restricted ability to open the mouth. It may progressively affect the entire oral cavity, and occasionally the pharynx. It has a strong link to areca nut (betel nut) chewing. The other proposed etiological factors include excessive chilly consumption, vitamin B12 and iron deficiency, tobacco ingestion, smoking, autoimmunity, and genetic and environmental factors. Treatment of oral submucous fibrosis is based on medical and surgical management along with physiotherapy, Conventional medical management includes avoidance of irritating substances like betel chewing, tobacco ingestion or smoking, etc., and involves regular administration of corticosteroids, either via submucosal injections or topical application. Corticosteroids have been considered the first-choice agent for the management of OSMF, However, continuous and prolonged use is associated with many systemic adverse effects such as bad taste, nausea, facial swellings, dryness, mucosal atrophy, candidal infection, granuloma formation, hypersensitivity reactions, delayed wound healing, and in later stages; hypothalamus pituitary adrenal suppression. Therefore, it is the need of an hour to establish an effective and efficient treatment modality for OSMF with lesser or no adverse effects. Platelet-rich plasma is the autologous component of the plasma and contains higher concentrations of platelets, growth factors, and cytokines than the basal level. Platelet-rich plasma (PRP) is a simple, efficient, and minimally invasive method. Platelet-rich plasma is an element of whole blood, prepared through centrifugation to a concentrated form. Platelet-rich plasma acts by inducing the platelets to secrete pro-inflammatory mediators and growth factors. These, in turn, initiate the cascade of wound healing and bring about tissue remodeling. This randomized controlled trial aims to compare the efficacy of the Injection dexamethasone and Hyaluronidase with the Injection of platelet-rich plasma (PRP) in the Management of Oral Submucous Fibrosis. By assessing parameters such as Mouth Opening (Interincisal distance), Burning Sensation (VAS Score), and Cheek flexibility. The study aims to evaluate the potential of PRP in alleviating symptoms and improving the condition of patients with OSMF. |