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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

                     

                                              

 
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