A Randomised, Double - blind, Multiple arm Trial toCompare the Efficacy of Submucosal injections of Hyaluronidase,Dexamethasone and Combination of Dexamethasone and Hyaluronidase inthe Management of Oral Submucous Fibrosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 1.Increase in mouth opening in millimetres.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 10.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients clinically diagnosed and histopathologically confirmed as OSF.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.Increase in mouth opening in millimetres.
Time Frame: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
2.decrease in subjective symptoms a) pain b) burning sensation of buccal mucosa c)tightness of buccal mucosa
Time Frame: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
all the above changes are acessed using numeric rating scale.d) protrusion of tongue relative to the alveolar ridge is asessed.
Time Frame: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
3.histopathologic improvements.
Time Frame: at the start of therapy | 2 weeks after final injection | 1 month, 2month, three month and 6 month after final injection
Secondary Outcomes
- 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)