COMPARISON OF EFFICACY OF PENTOXIFYLLINE AND LYCOPENE WITH INTRALESIONAL DEXAMETHASONE, HYALURONIDASE IN THE TREATMENT OF ORAL SUBMUCOUS FIBROSIS

Comparison of efficacy of Pentoxifylline and Lycopene with intralesional Dexamethasone, Hyaluronidase in the treatment of Oral Submucous Fibrosis: A Randomized Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087308

Enrollment

Registered

2025-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: T.Pentoxifylline 400mg: pentoxifylline, a xanthine derivative, known for its vasodilating capabilities and anti-inflammatory, fibrinolytic, immunomodulatory, effects. Pentoxifylline ha

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients of age 21-60 years clinically diagnosed with OSMF. 2. Patients who are willing to quit the habit of chewing tobacco and areca nut. 3. Patients who will agree to come for regular follow-up visits will be included.

Exclusion criteria

Exclusion criteria: 1. Patients who are currently under treatment for OSMF. 2. Patients under treatment for chronic systemic diseases such as Diabetes mellitus, Hypertension, Cardiovascular diseases, Bronchial asthma and Peptic ulcers. 3. Pregnant and lactating female patients. 4. OSMF patients with severe restricted mouth opening where there is no adequate access to administer intralesional injections. 5. Patients under treatment for other OPMDs.

Design outcomes

Primary

Measure	Time frame
mouth openingTimepoint: 18 months	—

Secondary

Measure	Time frame
Burning sensationTimepoint: 18 months	—

Countries

India

Contacts

Public ContactK J Jalin

GOVERNMENT DENTAL COLLEGE AND HOSPITAL,VIJAYAWADA

ramesh99inbox@gmail.com7032288366

Outcome results

None listed

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