Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting with clinical signs and symptoms of OSMF, with history of chewing or consuming tobacco, areca nut, pan masala, or gutka as the primary etiological factor, and having a score of 6 or below according to the classification given by SK Katharia. Patients who are willing to provide written informed consent and comply with the study protocol follow-up. Patient of either gender and disease severty- mild to moderate oral submucosal fibrosis.
Exclusion criteria
Exclusion criteria: Pregnancy or lactation, chronic debilitating conditions such as DM, HTN, HIV, Hepatitis B, bleeding disorders, cardiovascular diseases, renal dysfunction, liver disorders, mucosal disease or any other skin lesions and a known allergy or contraindication to the study drug. Patients on any treatment for OSMF. In case they are, then such a treatment would be Washout period of 2 weeks would be given. Pale oral mucosa of anemia mimicking blanching.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective parameters-difficulty in eating, chewing, uneasiness in swallowing, speaking will be recorded on LIKERT Scale, and burning sensation in mouth will be recorded on VAS Scale. Objective parameter- By Inter incisal distance (IID) to measure the change in mouth opening.Timepoint: At basline, third, sixth, ninth, and twelfth week | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
State Unani Medical College and Hospital