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Assessing the Impact of Oral Pentoxifylline and Vitamin E on Oral Submucous Fibrosis

DETERMINING EFFICACY OF ORAL PENTOXIFYLLINE AND VITAMIN E IN ORAL SUBMUCOUS FIBROSIS PATIENTS A PROSPECTIVE STUDY - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066118
Enrollment
60
Registered
2024-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: 3- Administration

Interventions

Intervention1: Oral submucous fibrosis: 30 oral submucous fibrosis patients meeting the inclusion and exclusion criteria will be given Oral pentoxifylline 400mg T.D.S for 3months. Control Interventio

Sponsors

Government College of Dentistry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)All new clinically diagnosed cases of OSMF between age group 18-55 years. 2)Patients who were willing to quit gutkha, areca nut and/or with tobacco chewing habit. 3)Patients who were ready to give their consent for the treatment.

Exclusion criteria

Exclusion criteria: 1)Patients who have disclosed medical history for major diseases. 2)Patients with coexisting disease or disorder of the orofacial region other than OSMF which may interfere with the study protocol. 3)Patients with or having a history of oral cancer. 4)Patients with the inadequate reference point (i.e. incisal edges of the central incisors) for measuring interincisal distance. 5)Patients with limited mouth opening reasons other than OSMF.

Design outcomes

Primary

MeasureTime frame
To eliminate the signs & symptoms, halt disease progression & reduce the predisposition for malignant transformation. Timepoint: baseline 1month 2month 3month 6months

Secondary

MeasureTime frame
1) To assess improvement in mouth opening. 2) To assess relief from intolerance to spicy food. 3) To evaluate difference in pain on opening mouth wide in control & study group. 4) To evaluate difference in cheek flexibility, tongue protrusion, blanching & depapillation of tongue and the extent of fibrous bands. Timepoint: baseline 1month 2month 3month 6months

Countries

India

Contacts

Public ContactDr. Yashika Kewalramani

Government College of Dentistry Indore

ajaycbct@gmail.com9860520075

Outcome results

None listed

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