Health Condition 1: K135- Oral submucous fibrosis Health Condition 2: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: Oral COX-2 inhibitors, surgery and aspirin mouth rinse: Celecoxib 100 mg tablet BD PO for 12 weeks followed by fibrotomy and buccal pad of fat graft, followed by aspirin mouth rinse tw
Sponsors
Applied for intramural grant RIMS Ranchi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Consecutive patients with clinically suspected OSMF will be considered for the study. 2. Patients with current or previous use of any form of smokeless tobacco and/or areca nut (any duration and frequency) 3. Patients having late-stage OSMF designated as Grade III and IV by the grading system proposed by Kerr et al. 4. Patients willing to quit the habit of smokeless tobacco and/or areca nut. 5. Patients willing to accept regular follow-up protocol 6. Histopathological confirmation of OSMF by incisional biopsy
Exclusion criteria
Exclusion criteria: 1. Patients having early-stage OSMF designated as Grade I and II by the grading system proposed by Kerr et al. 2. Patients with known allergy or contra-indication to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides. 3. Patients having diagnosis or treatment of esophageal, gastric, pyloric channel, or duodenal ulceration within past 30 days, prior or active pancreatic disease or inflammatory bowel disease or Hemophilia or a history of bleeding disorders or Gout or a history of gout 4. Patients already undergoing treatment for OSMF. 5. Pregnant and lactating females. 6. Patients having concomitant pericoronitis or any other dental condition leading to trismus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is clinical response in OSMF patients measured as a) Inter-incisal mouth opening b) Tongue protrusion c) Burning sensation/pain d) Relapse e) Clinical signs of malignant transformationTimepoint: Patients will be followed every 2 weeks during the 12-week pre-surgical period. later they will be followed up on the 7th, 15th, 30th day, 3rd, 6th, 9th, and 12th-month post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.COX-1 and COX-2 mRNA as assessed by qRT-PCR in tissue and saliva and COX-1 and COX-2 protein expression as assessed by immunohistochemistry in tissues and ELISA/Immunoblotting in saliva to determine whether COX inhibition in OSMF is actually possible by the use of the oral celecoxib and aspirin mouthwash formulation. 2. Comparison of the histopathological grade of OSMF between the incisional biopsy tissue and surgical specimen to assess tissue changes relating to altered tumor biology and compare them between anti-oxidants and celecoxib. 3. TGF-beta mRNA expression as assessed by qRT-PCR in tissue and saliva and protein expression assessed by immunohistochemistry in tissues and ELISA/Immunoblotting in saliva to determine. 4. Tolerability and possible oral and other adverse effects using a questionnaire Timepoint: Patients will be followed every 2 weeks during the 12-week pre-surgical period. later they will be followed up on 7th, 15th, 30th day, 3rd, 6th, 9th and 12th month post-surgery | — |
Countries
India
Contacts
Public ContactOm Prakash
RIMS, RANCHI
Outcome results
None listed