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CTRI Number  CTRI/2020/09/027836 [Registered on: 16/09/2020] Trial Registered Prospectively
Last Modified On: 01/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A novel approach for the treatment of oral submucous fibrosi by injection pentoxyphylline and dexamethasone  
Scientific Title of Study   “Comparison of Combination of Intralesional Pentoxyphylline and Dexamethasone, with Intralesional Pentoxyphylline, Intralesional Dexamethasone alone in Treatment of Oral submucous fibrosis.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SEEMA DENGRA 
Designation  ASSOCIATE PROF 
Affiliation  DATTA MEGHE INSTITUTE OF MEDISCAL SCIENCES. DEEMED TO BE UNIVERSITY.  
Address  Dept. of oral and maxillofacial surgery GOVT. DENTAL COLLEGE. RAJBANDHA MAIDAAN.RAIPUR CHATTISGARH
Dept. of oral and maxillofacial surgery SHARAD PAWAR DENTAL COLLEGE, SAWANGI, MEGHE. WARDHA Maharashtra 442004 India
Raipur
CHHATTISGARH
492001
India 
Phone    
Fax    
Email  seema_denggra@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Nitin Bhola 
Designation  PROFESSOR 
Affiliation  DATTA MEGHE INSTITUTE OF MEDISCAL SCIENCES. DEEMED TO BE UNIVERSITY.  
Address  Dept. of oral and maxillofacial surgery SHARAD PAWAR DENTAL COLLEGE, SAWANGI, MEGHE. WARDHA Maharashtra 442004 India
Dept. of oral and maxillofacial surgery SHARAD PAWAR DENTAL COLLEGE, SAWANGI, MEGHE. WARDHA Maharashtra 442004 India
Raipur
CHHATTISGARH
492001
India 
Phone    
Fax    
Email  cybervt1@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  SEEMA DENGRA 
Designation  ASSOCIATE PROF 
Affiliation  DATTA MEGHE INSTITUTE OF MEDISCAL SCIENCES. DEEMED TO BE UNIVERSITY.  
Address  Dept. of oral and maxillofacial surgery GOVT. DENTAL COLLEGE. RAJBANDHA MAIDAAN.RAIPUR CHATTISGARH
Dept. of oral and maxillofacial surgery SHARAD PAWAR DENTAL COLLEGE, SAWANGI, MEGHE. WARDHA Maharashtra 442004 India
Raipur
CHHATTISGARH
492001
India 
Phone    
Fax    
Email  seema_denggra@yahoo.co.in  
 
Source of Monetary or Material Support  
Sharad pawar dental college sawangi wardha Maharashtra 
 
Primary Sponsor  
Name  sharad pawar dental college wardha maharashtra 
Address  Datta Meghe institute of Medical sciences. ( deemed university) Sharad pawar dental college. sawangi (meghe) wardha. india  
Type of Sponsor  Research institution 
 
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 seema dengra  sharad pawar dental college and Hospital ,   Dept. of Oral and Maxillofacial Surgery.
Wardha
MAHARASHTRA 		 9752810701

seema_denggra@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Medical Sciences (deemed to be university) 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  Group I - combination of Injection Pentoxyfylline and injection Dexamethasone  1mg/ml Pentoxyfylline biweekly,3months. 4mg/ml dexamethasone biweekly for 3 months.  
Comparator Agent  Group II- Injection Pentoxyfylline Group III patients - Injection Dexamethasone  1mg/ml biweekly pentoxyfylline for 3 months. 4mg/ml dexamethasone biweekly for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients clinically diagnosed as having Grade II, III IV OSMF.
2) No obvious malignant disease in surroundings

 
 
ExclusionCriteria 
Details  1) Patient allergic or hypersensitive to the prescribed drugs. Patients who have previously exhibited intolerance to PTX or other xanthines such as caffeine, theophylline, etc.
2)Patient who have been treated with Intralesional injections/surgical modality.
3) Systemically compromised patients.
4) Pregnant or lactating mothers.
5) Patients with trismus of oral cavity due to reasons other than OSMF like TMJ ankylosis, Temporomandibular disorders, Myositis Ossificans etc.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
mouth opening  every 1 month for 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in burning sensation  every 1 month for 6 months 
quality of life  every 1 month for 6 months 
Functional improvement  every 1 month for 6 months 
Down staging of grading of Oral Submuacous fibrosis  every 1 month for 6 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2020 
Date of Study Completion (India) 15/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/11/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-10-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
The present randomized clinical study was undertaken to compare the efficacy of intralesional Pentoxyfylline combined with dexamethasone, intralesional pentoxyphylline alone, and intralesional dexamethasone alone in the management of Grade II and Grade III OSMF. A total of 75 patients were randomly allocated into three equal groups. Clinical parameters, including mouth opening and burning sensation, were evaluated along with ultrasonographic evaluation of submucosal thickness and Doppler evaluation of vascular parameters. The results demonstrated significant improvement in all treatment groups. However, combination therapy produced greater improvement in mouth opening, reduction in burning sensation, and decrease in submucosal thickness and favourable vascular changes as compared with either drug used alone. The study also established ultrasonography with Doppler as a useful objective and non-invasive method for monitoring treatment response in OSMF. The findings suggest that combining the antifibrotic and vasodilatory effects of Pentoxyphylline with the anti-inflammatory action of dexamethasone provides superior clinical outcomes in patients with Grade II and III OSMF.
 
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