What is the recommended dose of dexamethasone and hyaluronidase (HYAL (hyaluronidase)) injection for the treatment of submucosal fibrosis?

Recommended Dosing for Oral Submucous Fibrosis Treatment

For oral submucous fibrosis, the standard intralesional injection protocol consists of dexamethasone 4 mg combined with hyaluronidase 1500 IU, administered weekly for 12 weeks, which provides significant improvement in mouth opening and burning sensation. 1, 2

Standard Treatment Protocol

Injection Composition and Frequency

• Dexamethasone: 4 mg (1.5 ml) combined with hyaluronidase 1500 IU administered intralesionally 2, 3
• Add 0.5 ml lignocaine HCL for local anesthesia during injection 3
• Administer weekly injections for 12 weeks for optimal results 1
• Alternative biweekly dosing (every 2 weeks for 4 weeks) has also shown efficacy in Grade III disease 3

Expected Clinical Outcomes

• Mean increase in interincisal distance: 3.13 mm with the dexamethasone-hyaluronidase combination 2
• Maximum mouth opening improvement of 6 ± 2 mm (range 4-8 mm) achieved in 92% of Grade III patients 3
• Complete resolution of burning sensation typically occurs within the 12-week treatment period 1, 2
• Definite reduction in blanching of oral mucosa and painful ulceration 3

Treatment Algorithm Based on Disease Severity

Mild Cases (Interincisal Distance > 20 mm)

• Medical management with the standard dexamethasone-hyaluronidase protocol provides symptomatic relief 4
• Combine with oral vitamin B-complex supplements and daily mouth-opening exercises 4
• This approach is satisfactory for mild impairment but provides primarily symptomatic relief long-term 4

Severe Cases (Interincisal Distance < 20 mm / Grade III)

• Begin with the standard intralesional injection protocol (dexamethasone 4 mg + hyaluronidase 1500 IU weekly × 12 weeks) 1, 3
• If medical management fails, surgical excision of fibrotic bands with grafting becomes necessary 4, 5
• Buccal fat pad grafting shows superior long-term results compared to split-thickness skin or amnion grafts 4

Enhanced Combination Therapy

For maximum efficacy, combine intralesional injections with placentrex (placental extract) in addition to dexamethasone and hyaluronidase. 1

• This triple-drug combination produces the maximum increase in mouth opening (7.30 mm) compared to any single or dual therapy 1
• Shows minimum relapse rate (0.20 mm) at 12-month follow-up 1
• Administered as weekly injections for 12 weeks, followed by 12-month monitoring 1

Critical Adjunctive Measures

Mandatory Components for Success

• Complete cessation of betel quid/areca nut chewing before and throughout treatment is essential 4
• Daily mouth-opening exercises must be performed consistently throughout and after treatment 1, 4
• Monthly follow-up examinations for minimum 2 years to monitor for relapse 4

Alternative Agents in Resistant Cases

• Chymotrypsin can be added to the hyaluronidase-dexamethasone combination in treatment-resistant cases 5
• Submucosal placement of fresh human placental grafts after surgical excision shows success in severe resistant cases 5

Important Clinical Caveats

The combination of steroids and hyaluronidase shows better long-term results than either agent used individually. 3

• Medical treatment alone provides primarily symptomatic relief rather than complete regression in most cases 4
• Improvement is most significant in the first month of treatment, with continued gains through 12 weeks 2
• Tongue protrusion shows greater recovery at the end of the first month compared to later timepoints 2
• Without cessation of areca nut habit, treatment outcomes are significantly compromised regardless of protocol used 4