Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: torinol gd: This drug will be given postoperatively in patient surgically treated for oral submucous fibrosis FOR 2months postoperatively and patient will bw observed for six months p
Sponsors
AIIMS JODHPUR
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with clinically confirmed cases of oral submucous fibrosis. . 2.Patient with Mouth opening less than 25 mm. 3.Patients falling in the age group between 18 to 65 years. 4.Patient with good physical and mental condition. 5.Patient with absence of infection or trauma prior to the surgery.
Exclusion criteria
Exclusion criteria: Patients with recurrent OSMF. 2. Systemic illness affecting wound healing. 3. Patients currently on anticoagulant therapy ( e.g. warfarin , heparin , direct oral anticoagulants ) or long term corticosteroid / immunosuppressants . 4. Age <18 years and greater than 65 years. 5. Patients/with life-threatening cardio-respiratory co-morbidities with increasing risk of complication during GA like previous MI/under treatment for CAD, COPD patients, severe hepatic and renal impairment, patients with head injury (a condition that increased amount of pressure in the brain), opioid- tolerant patients. 6. A history of allergy to the drugs used in the present study. 7. All pregnant and lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the maximum interincisal mouth opening (MIO), expressed in millimetres, measured between the incisal edges of the upper and lower central incisors using a calibrated Vernier calliper. Measurements will be recorded at various time interval till 6months postoperatively 1.T0 Pre operatively 2.T1 1st day 3.T3 7th day 4.T5 15th day 5.T6 1st month 6.T7 3rd month 7.T8 6th month Timepoint: The primary outcome will be the maximum interincisal mouth opening (MIO), expressed in millimetres, measured between the incisal edges of the upper and lower central incisors using a calibrated Vernier calliper. Measurements will be recorded at various time interval till 6months postoperatively 1.T0 Pre operatively 2.T1 1st day 3.T3 7th day 4.T5 15th day 5.T6 1st month 6.T7 3rd month 7.T8 6th month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess Postoperative fibrosis (cheek extensibility, cheek flexibility, tissue suppleness, tongue protusion) at surgical site and compare clinical grading of fibrosis and photographic documentation at various time interval till 6months postoperatively. 2. To assess oral health related quality of life and compare change in OHIP-14 (or chosen QoL instrument) at various time interval till 6months postoperatively. 3. To assess treatment adherence/compliance and correlate adherence with outcomes. 4. To assess adverse events related to adjuvant drugs and compare incidence and severity of drug-related AEs (GI upset, dizziness, bleeding tendency, allergic reactions) using a standardized grading system. 5. To assess perioperative/postoperative complications and compare incidence and severity of complications (wound infection, graft failure, hematoma, nerve injury, reoperation).Timepoint: 1. T0 Pre operatively 2. T1 1st day 3. T3 7th day 4. T5 15th day 5. T6 1st month 6. T7 3rd month 7. T8 6th month | — |
Countries
India
Contacts
Public ContactDr Pallavi Gupta
AIIMS JODHPUR
Outcome results
None listed