| CTRI Number |
CTRI/2020/04/024470 [Registered on: 03/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dexamethasone Bioadhesive patch in the management of Oral Submucous Fibrosis - A non invasive approach |
|
Scientific Title of Study
|
Comparative Evaluation of the Efficacy of Dexamethasone Bioadhesive patch and Dexamethasone Intralesional injection in Oral Submucous Fibrosis-A Clinico-Sonographic Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Shree K R |
| Designation |
Postgraduate Student |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology,
Tamilnadu Government Dental College and Hospital,
1, Frazer Bridge Road, Muthuswamy salai, Opp to Fort station 5/126E, Dhanalakshmi Illam, Nehru Street, Anbu Nagar, Madurai - 625020 Chennai TAMIL NADU 600003 India |
| Phone |
8056825595 |
| Fax |
|
| Email |
krshilpashree@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa Shree K R |
| Designation |
Postgraduate Student |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology,
Tamilnadu Government Dental College and Hospital,
1, Frazer Bridge Road, Muthuswamy salai, Opp to Fort station
Chennai TAMIL NADU 600003 India |
| Phone |
8056825595 |
| Fax |
|
| Email |
krshilpashree@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Jayachandran MDS PhD FDSRCPSGlasg |
| Designation |
Professor and Head |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology,
Tamilnadu Government Dental College and Hospital,
1, Frazer Bridge Road, Muthuswamy salai, Opp to Fort station
Chennai TAMIL NADU 600003 India |
| Phone |
9444185662 |
| Fax |
|
| Email |
drsjayachandranmds@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Shilpa Shree K R,
Department of Oral Medicine and Radiology,
Tamilnadu Government Dental College and Hospital,
No.1 Frazer Bridge Road, Muthuswamy salai,
Chennai - 600003 |
|
|
Primary Sponsor
|
| Name |
Dr Shilpa Shree K R |
| Address |
Department of Oral Medicine and Radiology,
Tamilnadu Government Dental College and Hospital,No.1 Frazer Bridge road, Muthuswamy salai, Chennai - 3 |
| 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 Shilpa Shree K R |
Tamilnadu Government Dental College and Hospital |
Department of Oral Medicine and Radiology,Room No: 1-7,
1, Frazer Bridge road, Muthuswamy Salai, Chennai - 600003 Chennai TAMIL NADU |
8056825595
krshilpashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
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 |
| Intervention |
Dexamethasone bioadhesive (mucoadhesive) patch |
Dexmethasone sodium phosphate loaded mucoadhesive patch (2mg/patch) to be pasted in bilateral buccal mucosa biweeky for 6 weeks - 12 patches |
| Comparator Agent |
Dexamethasone Intralesional injection |
1.5ml of intralesional Inj. Dexamethasone sodium phosphate (4mg/ml) mixed with 0.5ml of lignocaine in bilateral buccal mucosa biweekly for 6 weeks - 12 injections |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of Oral Submucous fibrosis
2. Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Previously treated and Stage IVb OSMF cases
2.Other fibrosis conditions like scleroderma, scarring, post radiation therapy
3.Immunocompromised patients and other systemic disorders like hypertension and diabetes mellitus
4.Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant Decrease in the VAS score, Increase in the interincisal distance (mouth opening) and decrease in the submucosal thickness (measured via USG) in intervention group than comparator group |
Baseline,3rd week, 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better patient compliance in study group than comparator group as mucoadhesive patch is non invasive, painless and sustained release formulation |
baseline, after 6th week |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2020 |
| Date of Study Completion (India) |
08/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oral submucos fibrosis (OSMF), a
multifactorial oral potentially malignant disorder, is prevalent in South East
Asia particularly India with increasing prevalence of 0.3% to 6.42% and among
Chennai, South India is 8%. It is an insidious chronic disease affecting any
part of the oral mucosa, sometimes pharynx usually preceded by vesicle
formation and is always associated with juxtaepithelial inflammatory reaction
followed by a fibroelastic change of the lamina propria with
epithelial atrophy, leading to stiffness of oral mucosa causing trismus and
inability to eat. It leads to high rate of morbidity due to consequent nutritional
deficiencies.
Currently the most accepted management of
OSMF includes intralesional injection of steroids biweekly for 6 weeks.
Steroids are anti-inflammatory and anti-fibrotic. But the injections are
painful episodes and can also lead to scarring. Topical
dexamethasone loaded buccal bio-adhesive patch is a non invasive drug delivery
system which has been used successfully in the treatment of OSMF in
a pilot study.
Clinical diagnosis of OSMF is usually
made based on several characteristic clinical features. But those are
subjective and non reliable which leads to the need of quantitative imaging
technique to visualize and measure the clinical stage, progression of the
disease and its response to the treatment.
Hence this present study is designed
to to assess the burning sensation (Numerical rating scale), mouth opening
(interincisal distance), tongue protrusion, cheek flexibility, submucosal
thickness, echogenicity (USG assessment), patient compliance in oral
submucous fibrosis patients (OSMF) managed by dexamethosone loaded bio-adhesive
patch and intralesional injection at three time points, 0, 3rd and 6th week
respectively
|