Turmeric in oral submucous fibrosis.
- Conditions
- Health Condition 1: null- Oral submucous fibrosis
- Registration Number
- CTRI/2017/08/009461
- Lead Sponsor
- Jamia Millia Islamia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 147
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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