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CTRI Number  CTRI/2022/12/048322 [Registered on: 20/12/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of the efficacy of various treatment modalities in the management of mouth opening, burning sensation in oral submucous fibrosis 
Scientific Title of Study   Efficacy of treatment modalities of oral submucous fibrosis at clinical and histopathological level-Comparing intralesional corticosteroids in combination with hyaluronidases therapy, soft LASER (ErCr:YSGG)fibrotomy and intralesional autologous platelet-rich-plasma - A Prospective Randomized Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mekala Mary Sujatha 
Designation  Assistant professor 
Affiliation  Government dental college and hospital vijayawada 
Address  Room no:1 Department of oral medicine and radiology Government Dental College and Hospital, Gunadala, Vijayawada
Room no 1,Department of oral medicine and radiology Vishnu dental college, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
520004
India 
Phone  8179351022  
Fax    
Email  mmsujatha1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Ramesh 
Designation  Professor 
Affiliation  Vishnu Dental College and Hospital 
Address  Room no:1, Department of Oral medicine and radiology, Vishnu Dental College,Vishnupur,Bhimavaram-

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9440847997  
Fax    
Email  drramesht@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr T Ramesh 
Designation  Professor 
Affiliation  Vishnu Dental College and Hospital 
Address  Room no:1, Department of Oral medicine and radiology, Vishnu Dental College,Vishnupur,Bhimavaram-

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9440847997  
Fax    
Email  drramesht@gmail.com  
 
Source of Monetary or Material Support  
Government dental college and hospital, Vijayawada Krishna District, Andhra Pradesh 
Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh 
 
Primary Sponsor  
Name  Dr M Mary Sujatha 
Address  Room no:1, Department of Oral medicine and radiology, Government Dental College and Hospital, Vijayawada, Andhra Pradesh 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Mary Sujatha  Government Dental College and Hopsital  Room no:1, Department of Oral Medicine and Radiology, Government Dental College and Hopsital, Vijayawada
Krishna
ANDHRA PRADESH 
8179351022

mmsujatha1@gmail.com 
Dr M Mary Sujatha  Vishnu Dental College and Hospital  Room no:1, Department of Oral Medicine and Radiology, Vishnu Dental College and Hospital Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH 
8179351022

mmsujatha1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethics Committee  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  Erbium Chromium Yttrium Scandium Gallium Garnet (ErCr: YSGG) soft LASER fibrotomy  Erbium Chromium Yttrium Scandium Gallium Garnet (ErCr: YSGG) soft LASER fibrotomy once will be done 
Comparator Agent  Intralesional Corticosteroids in combination with hyaluronidases therapy  Corticosteroids (Inj. Dexamethasone 4mg) and Hyaluronidases (Inj Hyaluronidase 1500iu) will be given intralesionally once in a week in submucosal plane at multiple sites of palpable fibrous bands for 6 weeks. 
Intervention  Platelet rich plasma therapy  Autologous PRP 5ml will be given intralesionally in submucosal plane at multiple sites of palpable fibrous bands at about 0.5ml per 1cm2 using 25-gauge needle for 6 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. The individuals who gave a positive history of Areca nut/ Ghutka / Betel Quid chewing.
2. The criteria for the presence of the disease according to clinical staging and clinical inspection:Burning sensation, the presence of fibrous bands, Restricted mouth opening.
3. Histologically proven oral submucous fibrosis.
 
 
ExclusionCriteria 
Details  1 Patient with blood-borne diseases
2 Medically compromised patients
3 Anti-coagulant therapy
4 Immunosuppressive therapy
5 Critical thrombocytopenia (low platelet count)
6 Hypofibrinogenemia.
7 Hemodynamic instability
8 Individuals with history of any systemic disease and undergoing treatment.
9 Individuals not willing to be a part of study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To know efficacy of the each treatment modality Intralesional Injections, PRP injections, Laser therapy in Oral submucous fibrosis clinically in reduction of fibrous bands, burning sensation of mouth increase in mouth opening.   1. Reduction of fibrous bands: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months.
2. Reduction in burning sensation of mouth: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months.
3. Increase in mouth opening: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   01/06/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Oral submucous fibrosis is the most common potentially malignant disorder of Indian subcontinent resulting in severe morbidity of trismus. In the present study four treatment modalities like intralesional Corticosteroids, Intralesional Hyaluronidase, Intralesional autologous Platelet-rich-plasma and LASER(Er-Cr-YSGG) fibrotomy have been selected to treat each group of patients randomly. This study is a Prospective Randomized Clinical four-arm Trail of the sample size 84 subjects. Each group has 21 subjects are intended to know the efficacy of the four treatment modalities clinically and histologically. Each subject of the three intralesional groups are treated weekly once for 6 weeks respectively. The LASER fibrotomy is undertaken in fourth group. Each subject of all the groups is followed at an interval of 3months, 6months,9months for the prognostic changes of clinical symptoms. The outcomes are subjected to statistical analysis using G*power. One way analysis of variance. Type1 - error of 5%, Effect size :0.8. Anticipated dropout rate 10%. Each variant of clinical symptoms is compared among the groups anticipating the hypothesis of intralesional autologous Platelet-rich-plasma is novel less invasive regenerative, remodeling treatment modalities and patient compliance in reducing morbid conditions like trismus. 

 
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