To evaluate the expression of TGF beta1, SMAD4 and SMAD7 in oral submucous fibrosis and oral cancer with treatment response in oral submucous fibrosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019414

Enrollment

135

Registered

2019-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Intralesional hyaluronidase with dexamethasone along with coconut oil pulling: Intralesional hyaluronidase 1500IU with dexamethasone 2ml once a week for 8 weeks along with coconut oil p

Eligibility

Inclusion criteria

Inclusion criteria: Clinically and histopathologically proven cases of OSMF

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate 2. patients with severe uncontrolled systemic disease and pregnancy

Design outcomes

Primary

Measure	Time frame
Mouth opening, Tongue protrusion, Cheek flexibility and VAS scoreTimepoint: Pre treatment and at 6 months	—

Secondary

Measure	Time frame
Reporting of any malignant transformation over a period of 6 monthsTimepoint: Individuals will be assessed Every 4 weeks and in case of any suspicion, biopsy will be done	—

Countries

India

Contacts

Public ContactDr Ridam Sharma

Maulana Azad Institute of Dental Sciences

drsunitagupta@yahoo.com9953535548

Outcome results

None listed

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