None listed
Conditions
Interventions
Intervention1: Immusante Tablet (Himalaya Drugs): 2 tablets twice daily before food (once in morning and evening) for 3 months with water.
Control Intervention1: Oxitard capsules (Himalaya Drugs): 2 c
Sponsors
Dr D Y Patil Dental College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who are ready to quit the habit of tobacco chewing and accepted for regular follow ups. 2)Patients with early stages of Oral submucous fibrosis diagnosed clinically and functionally according early stages of Chandramani More et al (2011) classification: Early clinical/functional staging consist of: Clinical staging: Stage 1(S1):Stomatitis and/or blanching of oral mucosa Stage 2(S2): Presence of palpable fibrous bands in buccal mucosa and/or oropharynx, with/without stomatitis. Functional staging: M1: Interincisal mouth opening up to or greater than 35 mm. M2: Interincisal mouth opening between 25 and 35 mm 4)Patients who had not undergone any treatment earlier for oral submucous fibrosis.
Exclusion criteria
Exclusion criteria: 1)Patients who did not give their consent for participation. 2)Patients with any other oral lesions/conditions other than Oral submucous Fibrosis. 3)Pregnant women and Lactating mothers. 4) Any history of allergy/adverse reaction to similar pharmaceutical products, its components or ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in burning sensation, difficulty in speaking and eating will be recorded using VAS(Visual Analog Scale) 2. Improvement in mouth opening will be measured with a geometric scale. 3.Improvement in tongue protrusion will be assessed in units of a millimeter. 4.Improvement in cheek flexibility will be recorded in mm using technique previously published by Reddy et al 2011. 5.Improvement in gingival health will be evaluated using plaque index and gingival index. Timepoint: Baseline, At the end of 1month, At the end of 3month | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: 0 | — |
Countries
India
Contacts
Public ContactDr Sahana Hegde Shetiya
Dr D Y Patil Dental college and Hospital
Outcome results
None listed