Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: To assess the levels of salivary malondialdehyde (MDA) in patients with Stage 1 and Stage 2 Oral Submucous Fibrosis (OSMF) before and after treatment with oral lycopene.: 1. To evaluate
Sponsors
Government college of dentistry indore Madhya pradesh India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed and classified Stage 1 and Stage 2 patients with Oral Submucous Fibrosis (OSMF) [according to Chandramani More et al. classification]. 2. Patients aged between 18 years and above. 3. Informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Patients with history of systemic diseases and medications for any systemic diseases. 2. Patients who are currently on any other antioxidant therapy or supplements. 3. Patients who have recently undergone surgical interventions or other treatment for OSMF. 4. Patients with known hypersensitivity or allergies to lycopene or any of its components. 5. Patients with OSMF who are indicated for treatment modalities other than oral lycopene. 6. Patients with alcohol consumption habit. 7. Patients complaining of difficulty in mouth opening due to other reasons like inflammation/infection, trauma and temporo mandibular joint disorders. 8. Pregnant and lactating mother. 9. Patients with history of cancer or having family history of cancer. 10. Patients with salivary gland disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in salivary malondialdehyde levels from baseline before initiation of oral lycopene therapy to 3 months after oral lycopene therapy in patients with Stage 1 and Stage 2 Oral Submucous Fibrosis.Timepoint: Baseline before initiation of oral lycopene therapy and at 3 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in salivary malondialdehyde levels from baseline before initiation of oral lycopene therapy to 3 months after oral lycopene therapy in patients with Stage 1 & Stage 2 Oral Submucous Fibrosis.Timepoint: Baseline before initiation of oral lycopene therapy & at 3 months (12 weeks) after completion of treatment. | — |
Countries
India
Contacts
Public ContactDr Jagrati Singh Rajput
Government college of dentistry jaora compound Indore
Outcome results
None listed