Treatment response of Green Tea capsule, Intralesional inj. of Hyaluronidase, Dexamethasone, Placentrix and Sesame Oil Pulling in OSMF

Comparison of Two Treatment Modalities and Role of SIRT3 & SSEA4 as Critical Regulators at the Cross-Roads between Oral Submucous Fibrosis (OSMF) and Oral Cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033485

Enrollment

Registered

2021-05-07

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: Green Tea Extract 500 mg: Green Tea extract 500 mg orally twice daily for 6 months Control Intervention1: Inj. Hyaluronidase 1500 IU, Inj. Dexamethasone 4 mg/ml, Inj. Placentrix 2 ml an

Eligibility

Inclusion criteria

Inclusion criteria: Clinically and histopathologically proven cases of OSMF and OSCC. Subjects with prior informed consent.

Exclusion criteria

Exclusion criteria: Patients who are not willing to participate. Patients with severe systemic disease. Pregnant and nursing women. Subjects with mouth opening less than 15 mm.

Design outcomes

Primary

Measure	Time frame
Mouth Opening, Tongue Protrusion, Cheek flexibility, VAS ScaleTimepoint: Pre-Treatment, 1 month, 3 months and at the end of 6 months	—

Secondary

Measure	Time frame
Reporting of any malignant transformation in the span of 6 monthsTimepoint: Every 4 weeks till 6 months	—

Countries

India

Contacts

Public ContactDr Pavithra R

Maulana Azad Institute of Dental Sciences

profsunitamamc@gmail.com9654700955

Outcome results

None listed

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