Health Condition 1: null- oral submucous fibrosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients above the age of 18 years 2.Male and female subjects diagnosed with OSMF according to the criteria by Warnakulasuriya et al. 3.A positive history of chewing of the areca nut or one of its commercial preparations 4.Patients who have not been on any treatment for OSMF for at least 2 months prior to their recruitment in the study
Exclusion criteria
Exclusion criteria: 1.Patients with mouth opening less than 15 mm 2.Patients with other coexisting mucosal lesions such as leukoplakia and malignancies. 3.The patients who have undergone radiotherapy of the head and neck 4.History of allergy to Aloe vera or Lycopene 5.History of systemic disorders like chronic liver disease, gastrointestinal disorders and patients on laxatives, diuretics and on medication for diabetes and cardiovascular disease. 6.Patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to measure the improvement in VAS burning sensation and mouth openingTimepoint: baseline , 1 month, 2 month | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure the improvement in tongue protrusion and cheek flexibilityTimepoint: Baseline, 1 month,2 month | — |
Countries
India
Contacts
Rajiv Gandhi University of Health Sciences