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Effect of two drugs for treatment of Oral Submucous Fibrosis

Pre and Post treatment expression of p53, iNOS and TGF in potentially malignant oral disorders

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007732
Enrollment
56
Registered
2017-01-20
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 Health Condition 2: K121- Other forms of stomatitis

Interventions

Intervention1: Tablet Curcumin 300 mg: Tablet was administerd orally thrice daily for 9 months Intervention2: Group A: Tablet Curcumin & Piperine 300 mg: 300 mg Tablet was administered orally thrice d

Sponsors

Maulana Azad Institute of Dental Sciences
Lead Sponsor
Indian Council of Medical Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: •Clinically & Histopathologically proven case of OSMF 1)A positive history of chewing areca nut or one of its commercial preparation, difficulty in swallowing and chewing, and burning sensation on eating spicy foods.81 2)Restricted mouth opening and changes in the oral mucous membrane including the presence of palpable vertical fibrous bands, stiffness and blanching.81 •Positive habit history of tobacco, smoking, betel quid, and alcohol.

Exclusion criteria

Exclusion criteria: •Those who were not willing to participate. •Patients who were already undertaking some treatment for existing potentially malignant oral disorder. •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 groupTimepoint: Patients were assessed clinically every 4 weeks for 9 months

Secondary

MeasureTime frame
Reporting of Malignant transformation over period of 9 monthsTimepoint: individuals were assesses every 4 weeks for 9 months. in case of any suspicion, biopsy was done.

Countries

India

Contacts

Public ContactDr Shikha

Maulana Azad Institute of Dental Sciences

drsunitagupta@yahoo.com9654700955

Outcome results

None listed

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