| CTRI Number |
CTRI/2014/10/005155 [Registered on: 30/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
30/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study and compare the effects of hyaluronidase, dexamethasone and their combination in patients with oral submucous fibrosis |
|
Scientific Title of Study
|
A Randomised, Double - blind, Multiple arm Trial to
Compare the Efficacy of Submucosal injections of Hyaluronidase,
Dexamethasone and Combination of Dexamethasone and Hyaluronidase in
the Management 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 |
Dr Rajitha A V |
| Designation |
pg student |
| Affiliation |
govt.dental college,calicut |
| Address |
PG student, Dept of OMR, Govt Dental college, Calicut
govt dental college,medical college campus,chevayoor,calicut,673008
Kozhikode
KERALA
673008
India |
| Phone |
9400444492 |
| Fax |
914952356781 |
| Email |
raji_nbr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Balan |
| Designation |
professor and head |
| Affiliation |
govt.dental college,calicut |
| Address |
Head of the Dept, Dept. of OMR,Govt Dental college, Calicut
govt dental college,medical college campus,chevayoor,calicut,673008
Kozhikode
KERALA
673008
India |
| Phone |
9447800944 |
| Fax |
914952356781 |
| Email |
anitabalan4@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Balan |
| Designation |
professor and head |
| Affiliation |
govt.dental college,calicut |
| Address |
Head of the Dept, Dept. of OMR,Govt Dental college, Calicut
govt dental college,medical college campus,chevayoor,calicut,673008
Kozhikode
KERALA
673008
India |
| Phone |
9447800944 |
| Fax |
914952356781 |
| Email |
anitabalan4@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| goverment dental college, kozhikode, kerala |
|
|
Primary Sponsor
|
| Name |
STATE BOARD OF MEDICAL RESEARCH |
| Address |
govt dental college,medical college campus, kozhikode |
| Type of Sponsor |
Government funding agency |
|
|
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 RAJITHA AV |
OPD,government dental college kozhikode |
Room no.9, Department of OMR
Government Dental college kozhikode
Kozhikode
KERALA |
9400444492
914952356781
raji_nbr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Govt Dental college, Calicut, Kerala, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Oral submucous fibrosis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injection hyaluronidase- HYANIDASE |
biweekly submucosal injection of hyaluronidase 1500 I.U diluted with 2 ml of water for injection and 1ml of 2% lignocaine with adrenaline (1:80000)using 27 gauge needle for a period of 5 weeks |
| Comparator Agent |
INJECTION OF COMBINATION OF DEXAMETHASONE AND HYALURONIDASE |
biweekly submucosal injection of combination of dexamethasone 1 ml (4mg/ml)and 1 part of hyaluronidase 1500 I.U diluted with 1 ml of water for injection and 1ml of 2% lignocaine with adrenaline (1:80000)using 27 gauge needle for a period of 5 weeks |
| Intervention |
injecttion dexatmethasone- DEXONA |
biweekly submucosal injection of dexamethasone 2 ml (4mg/ml) with 1ml of 2% lignocaine with adrenaline (1:80000)using 27 gauge needle for a period of 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically diagnosed and histopathologically confirmed as OSF
|
|
| ExclusionCriteria |
| Details |
Patients having severe systemic problems or pregnant ladies,
patients having history of drug allergy or hypersensitivity to hyaluronidase, dexamethasone or lignocaine,
a previous history of treatment for OSF or malignancy arising in OSF or patients unwilling for treatment
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Increase in mouth opening in millimetres.
2.decrease in subjective symptoms a) pain b) burning sensation of buccal mucosa c)tightness of buccal mucosa
all the above changes are acessed using numeric rating scale.d) protrusion of tongue relative to the alveolar ridge is asessed.
3.histopathologic improvements. |
at the start of therapy
2 weeks after final injection
1 month, 2month, three month and 6 month after final injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Increase in mouth opening in millimetres.
2.decrease in subjective symptoms a) pain b) burning sensation of buccal mucosa c)tightness of buccal mucosa
all the above changes are acessed using numeric rating scale.d) protrusion of tongue relative to the alveolar ridge is acessed.
3.histopathologic improvements. |
after one year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Numerous treatment modalities have been advocated for oral submucous fibrosis over years, but it is not yet fully standardized. Moreover , RCT’s are lacking. This RCT is done to acess a better treatment option. The efficacy of local sub-mucosal injections of hyaluronidase, dexamethasone and their combinations are tested and evaluated for improvements in mouth opening, pain , burning sensation and tongue protrusion. The results are compared and confirmed with subsequent histopathological studies. |