Health Condition 1: null- Oral submucous fibrosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients satisfying all the inclusion criteria were enrolled which included current or previous use of any form of smokeless tobacco and/or areca nut (any duration and frequency); complains of burning sensation of mouth on having hot and spicy food and/or difficulty in swallowing and chewing; and presenting with clinical features like restricted mouth opening and/or changes in the oral mucous membrane including presence of vertical fibrous bands, stiffness, blanching and circum oral bands.
Exclusion criteria
Exclusion criteria: Patients with significant medical condition as defined by the investigator that interfered with the safety, treatment or compliance with the protocol; patients with known allergy or contra-indication to any of the ingredients of the antioxidants or turmeric; pregnant and lactating females; patients already undergoing treatment for OSMF and patients having concomitant pericoronitis or any other dental condition leading to trismus were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes studied were inter-incisal mouth opening; tongue protrusion and burning sensation on having food was recorded using Visual Analogue Scale (VAS) from 1 to 10 (with 10 being the most severe).Timepoint: every 15 days for 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes studied were adverse reactions reported with the drugs used; habit cessation success rate and change in the color of mucosa (recorded as white, pale or pink).Timepoint: every 15 days for 3 months | — |
Countries
India
Contacts
Jamia Millia Islamia