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A novel approach for the treatment of oral submucous fibrosi by injection pentoxyphylline and dexamethasone

â??Comparison of Combination of Intralesional Pentoxyphylline and Dexamethasone, with Intralesional Pentoxyphylline, Intralesional Dexamethasone alone in Treatment of Oral submucous fibrosis. ?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027836
Enrollment
75
Registered
2020-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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: Group I - combination of Injection Pentoxyfylline and injection Dexamethasone: 1mg/ml Pentoxyfylline biweekly,3months. 4mg/ml dexamethasone biweekly for 3 months. Control Intervention1

Sponsors

sharad pawar dental college wardha maharashtra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients clinically diagnosed as having Grade II, III IV OSMF. 2) No obvious malignant disease in surroundings

Exclusion criteria

Exclusion criteria: 1) Patient allergic or hypersensitive to the prescribed drugs. Patients who have previously exhibited intolerance to PTX or other xanthines such as caffeine, theophylline, etc. 2)Patient who have been treated with Intralesional injections/surgical modality. 3) Systemically compromised patients. 4) Pregnant or lactating mothers. 5) Patients with trismus of oral cavity due to reasons other than OSMF like TMJ ankylosis, Temporomandibular disorders, Myositis Ossificans etc.

Design outcomes

Primary

MeasureTime frame
mouth openingTimepoint: every 1 month for 6 months

Secondary

MeasureTime frame
reduction in burning sensationTimepoint: every 1 month for 6 months;quality of lifeTimepoint: every 1 month for 6 months;Functional improvementTimepoint: every 1 month for 6 months;Down staging of grading of Oral Submuacous fibrosisTimepoint: every 1 month for 6 months

Countries

India

Contacts

Public ContactSEEMA DENGRA

DATTA MEGHE INSTITUTE OF MEDISCAL SCIENCES. DEEMED TO BE UNIVERSITY.

cybervt1@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026