A clinical trial to study and compare the effects of hyaluronidase, dexamethasone and their combination in patients with oral submucous fibrosis

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005155

Enrollment

Registered

2014-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Oral submucous fibrosis

Interventions

Intervention1: injection dexamethasone,injection hyaluronidase,combination of above two: 1.biweekly local submucosal injections of hyaluronidase 1500 IU diluted with 1ml of 2% lignocaine with adrenal

2.biweekly local submucosal injections of dexamethasone 2ml(4mg/ml) with 1ml of 2% lignocaine with adrenaline for a period of 5 weeks

3.biweekly local submucosal injections of combination of dexamethasone 1ml(4mg/ml) and one part of hyluronidase diluted with 1ml of 2% lignocaine with adrenaline and 1ml of water for injection for a p

Eligibility

Inclusion criteria

Inclusion criteria: Patients clinically diagnosed and histopathologically confirmed as OSF

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: at the start of therapy 2 weeks after final injection 1 month, 2month, three month and 6 month after final injection	—

Measure

Time frame

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.Timepoint: at the start of therapy 2 weeks after final injection 1 month, 2month, three month and 6 month after final injection

—

Secondary

Measure	Time frame
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.Timepoint: after one year	—

Countries

India

Contacts

Public ContactDr Anita Balan

govt.dental college,calicut

anitabalan4@yahoo.co.in9447800944

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026