| CTRI Number |
CTRI/2020/09/027836 [Registered on: 16/09/2020] Trial Registered Prospectively |
| Last Modified On: |
14/09/2020 |
| 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
|
|
|
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
|
|
|
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)= "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)
|
20/09/2020 |
| 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="1"
Months="6"
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
|
This study is a randomized single blind parallel group single centered trial comparing the efficacy of combination of intralesional Pentoxyphylline 1mg/ml and intralesional dexamethasone 4ml biweekly for 3 months with intralesional pentoxyphylline and intralesional dexamethasone alone in 75 patients in oral submucous fibrosis patients that will be conducted at one centre in India. The primary outcome measure will be Interincisal opening at 6 months. The secondary outcomes will be reduction in burning sensation, functional improvement, quality of life, downstaging of Grading of oral submucous fibrosis will be measured every 1 month for 6 months. |