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Various treatment modalities like oils, tablets and mouthwashes would be given for the treatment of oral submucous fibrosis.

To evaluate the response of different treatment modalities in oral submucous fibrosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015166
Enrollment
500
Registered
2018-08-02
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: Lycopene: Its is an antioxidant and would be given in a tablet form twice daily for a period of 3 months Control Intervention1: Sesame oil, olive oil, lycopene and turmix: To assess the

Sponsors

Maulana Azad institute of dental sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A sufficient number of sample of patients suffering from oral submucous fibrosis would be taken. They would be subjected to different systemic and topical antioxidants . The improvement in mouth opening, tongue protrusion, VAS scale and cheek flexibility would be assessed.

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating mothers 2. Patients less than 18 years 3. Patients having intolerance to any of the drugs to be used in the study 4.Those not willing to participate. 5.Patients already undergoing some treatment for existing OSMF

Design outcomes

Primary

MeasureTime frame
1. Mouth opening 2. VAS Scale 3. Burning sensation 4. Cheek flexibility Timepoint: Patients would be assessed after 15 days initially followed by 1 month.

Secondary

MeasureTime frame
to assess the side effects of the drugs given , malignant potential of the diseaseTimepoint: the drugs would be given for a period of 3 months.

Countries

India

Contacts

Public ContactDr Shriya khera

Maulana Azad institute of dental sciences, New Delhi

shriyakhera1988@gmail.com9915803696

Outcome results

None listed

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