Skip to content

Comparison of efficacy of Intralesional Xanthinol Nicotinate with Intralesional Platelet Rich Plasma (PRP) in the treatment of Oral Submucous Fibrosis

Comparison of efficacy of Intralesional Xanthinol Nicotinate with Intralesional Platelet Rich Plasma (PRP) 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/2025/12/099331
Enrollment
30
Registered
2025-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: XANTHINOL NICOTINATE 150mg/2ml: Patients will be administered Intralesional injection of Xanthinol Nicotinate 150mg/2ml twice a week combined with oral antioxidant tablets containing Sp

Sponsors

Ch Thabitha
Lead Sponsor

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 with chronic systemic diseases and Blood disorders 3. OSMF patients with severe restricted mouth opening where there is no adequate access to administer intralesional injections 4. Patients under treatment for other OPMDs 5. Pregnant and lactating patients.

Design outcomes

Primary

MeasureTime frame
MOUTH OPENINGTimepoint: 18 MONTHS

Secondary

MeasureTime frame
BURNING SENSATIONTimepoint: 18 MONTHS

Countries

India

Contacts

Public ContactCh Thabitha

Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada

ramesh99inbox@gmail.com6300044525

Outcome results

None listed

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