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To study effects of two different drugs in treatment of Oral Submucous Fibrosis

To evaluate the treatment response and expression of hMLH1, MDM2 & p63 in oral potentially malignant disease.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009671
Enrollment
45
Registered
2017-09-06
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: null- Oral Submucous Fibrosis

Interventions

Intervention1: Group A : Tablet Curcumin & Piperine 300mg: 300 mg tablets were administered two times daily for 6 months. Intervention2: Group B: Oral lycopene: Total dose of 16mg given twice daily fo

Sponsors

Maulana Azad Institute Of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically and histopathologically proven cases of OSMF 1) Positive history of chewing areca nut or one of its commercial preparation, difficulty in swallowing and chewing, and burning sensation on eating spicy food. 2) Restricted mouth opening and changes in the oral mucous membrane including the presence of vertical fibrous bands , stiffness and blanching. 30 positive history of tobacco, smoking, betel quid and alcohol.

Exclusion criteria

Exclusion criteria: 1) Those who were not willing to participate. 2)Patients who were already undertaking some treatment for existing potentially malignant disorder. 3)Patients with severe systemic disease.

Design outcomes

Primary

MeasureTime frame
Evaluation of burning sensation score, mouth opening, tongue protrusion and cheek flexibility between groups and within groupsTimepoint: At the time of first visit, every month till a period of 9 months.

Secondary

MeasureTime frame
Reporting of malignant transformation over period of 9 months.Timepoint: Individuals were assessed every 4 weeks for 9 months. In case of any suspicion, biopsy was done.

Countries

India

Contacts

Public ContactDr Sunita Gupta

Maulana Azad Institute of Dental Sciences

drsunitagupta@yahoo.com9654700955

Outcome results

None listed

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