| CTRI Number |
CTRI/2024/01/061403 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison of the effectiveness of placentrex, hyaluronidase, and dexamethasone in the treatment of Oral submucous fibrosis. |
|
Scientific Title of Study
|
Comparative assessment of efficacy of intralesional injection of placentrex, hyalouronidase and dexamethasone in treatment of Oral submucous fibrosis- A randomized control 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 |
Jay Goyal |
| Designation |
Associate Professor |
| Affiliation |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College |
| Address |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College Sakri Road
Dhule
MAHARASHTRA
424001
India
Dhule
MAHARASHTRA
424001
India |
| Phone |
8081259757 |
| Fax |
|
| Email |
dentopathfider2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jay Goyal |
| Designation |
Associate Professor |
| Affiliation |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College |
| Address |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College Sakri Road
Dhule
MAHARASHTRA
424001
India
Dhule
MAHARASHTRA
424001
India |
| Phone |
8081259757 |
| Fax |
|
| Email |
dentopathfider2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jay Goyal |
| Designation |
Associate Professor |
| Affiliation |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College |
| Address |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College Sakri Road
Dhule
MAHARASHTRA
424001
India
Dhule
MAHARASHTRA
424001
India |
| Phone |
8081259757 |
| Fax |
|
| Email |
dentopathfider2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College Sakri Road |
|
|
Primary Sponsor
|
| Name |
Jay Goyal |
| Address |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College Sakri Road |
| 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 Jay Goyal |
Jawahar Medical Foundations Aannasaheb Chudaman Patil Memorial Dental College |
Room no 2, Department of Oral Surgery
Dhule
MAHARASHTRA |
8081259757
dentopathfider2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug administration |
Intralesional injections of Placentrex in group 2, Hyaluronidase and dexamethasone in group 3, and Combination of Placentrex, Hyaluronidase, and dexamethasone in group 4 will be given weekly for 12 weeks and follow-up will be done for 12 months |
| Comparator Agent |
Oral suppliments |
Group 1 OSMF patients will be given only oral supplements and mouth exercises for 12 weeks and follow up will be done for 12 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The patients diagnosed with Grade 2, and Grade 3 of oral submucous fibrosis (OSMF), as evident from their detailed clinical and histopathological examination |
|
| ExclusionCriteria |
| Details |
The patients with previous treatment of OSMF, patients who had Grade 1 and 4 OSMF, who were allergic to placental extract, steroids, and hyaluronidase, the patients who did not give their consents, who have syndromic or systemic disease with mouth ulcers, who had undergone radiotherapy sessions leading to oral ulcers, those who gave previous history of major surgery in the oral cavity, patients with carcinoma of oral cavity, were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The significant increase in the mouth-opening and relief of burning sensation with combination intralesional injection therapy in OSMF |
at Baseline, 4th week, 8th week, 12th week and 12th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The significant increase in the mouth-opening and relief of burning sensation with combination intralesional injection therapy in OSMF |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dentopathfider2009@gmail.com].
- For how long will this data be available start date provided 15-12-2024 and end date provided 23-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Oral submucous fibrosis (OSMF) is a very
common premalignant condition in India, with high rates of malignant
transformation. The most prevalent are Grade 2 and 3 OSMF cases, and therefore,
various treatment modalities have been tried in these cases. The aim of the
present study was to compare the efficacy of intralesional injection of placentrex, hyaluronidase, and dexamethasone in the treatment of OSMF
A single-center open label randomized
control trial will be conducted on 160 patients of Grade 2 and 3 OSMF, divided into
four groups as follows: Group 1: 40 patients who will have various oral
supplements only; Group 2: 40 patients will be given intra-lesional injection of 2ml
placentrex, mixed with 1ml of 2% lignocaine; Group 3: 40 patients will have injection of 1500 IU of 1ml hyaluronidase, with 1ml dexamethasone, mixed with
1ml of 2% lignocaine; Group 4: 40 patients will receive a combination of the
above 2 groups (2ml placentrex, 1ml hyaluronidase, 1ml dexamethasone, mixed
with 1 ml of 2% lignocaine). The patients will be evaluated for mouth opening, and
burning sensation with Likert five-point scale at baseline, one week, fourth week,
eighth week, twelfth week, and twelfth month. Analysis of variance (ANOVA) will be used for inter, and intra-group comparison for assessment of mouth opening,
and Kruskal Wallis test will be used for assessment of burning sensation. |