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Clinical Study of Mucoadhesive Patch and Lycopene Therapy in Oral Submucous Fibrosis

COMPARATIVE EVALUATION OF DEXAMETHASONE HYALURONIDASE MUCOADHESIVE PATCH AND LYCOPENE WITH LYCOPENE MONOTHERAPY IN ORAL SUBMUCOUS FIBROSIS: A RANDOMIZED CONTROLLED TRIAL. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110641
Enrollment
30
Registered
2026-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue Health Condition 2: K135- Oral submucous fibrosis

Interventions

Intervention1: MUCOADHESIVE PATCH OF DEXAMETHASONE AND HYALURONIDASE with 4mg lycopene tablet: Patients (15 subjects) will be given mucoadhesive patch having combination of 4mg of dexamethasone 0.5 m

Sponsors

Dr Aishwarya Bhave
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient age group between 16 to 60 years. No history of prior treatment for the same. Patients with OSMF stage II

Exclusion criteria

Exclusion criteria: Patients with known history of hypersensitivity to dexamethasone , hayluronidase & Lycopene. Patients who are diagnosed with other intra oral lesions. Pregnant women and lactating mothers. Immunocompromised patients.

Design outcomes

Primary

MeasureTime frame
Decrease in Burning Sensation and increase Interincisal Mouth OpeningTimepoint: Base line, 1 month ,2 month—

Secondary

MeasureTime frame
nilTimepoint: nil—

Countries

India

Contacts

Public ContactDr.Aishwarya Bhave

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna

ashish.lanjekar@sdk-dentalcollege.edu.in09595052481

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026