Effectiveness of a mouth opening device in improving mouth opening in Oral Submucous Fibrosis Patients A Randomized Clinical Trial

INTERVENTION: Intervention1: Intralesional injection of Dexamethasone 4 mg with Hyaluronidase 1500 with Mouth opening device: Administer intralesional injection of Dexamethasone 4mg with Hyaluronidase 1500 IU weekly Injection sites: bilateral buccal mucosa (1 ml per side). Duration: Once a week for 6 weeks. Provide and demonstrate usage of the Mouth Opening Device.Explain usage schedule: 3 sessions/day, 15 minutes/session. Instruct patients to gradually increase pressure as tolerated. Provide a patient logbook to monitor daily usage and compliance. Control Intervention1: Intralesional injection of Dexamethasone 4 mg with Hyaluronidase 1500 IU: Administer intralesional injection of Dexamethasone 4mg with Hyaluronidase 1500 IU weekly. Injection sites: bilateral buccal mucosa (1 ml per side). Duration: Once a week for 6 weeks. CONDITION: Health Condition 1: K135‐ Oral submucous fibrosis PRIMARY OUTCOME: Increase in interincisal mouth opening (mm).Timepoint: 3rd week, 6th week SECONDARY OUTCOME: 1. Reduction in burning sensation (VAS score) ; 2. Improvement in oral health‐related quality of life (OHIP‐14 score)Timepoint: 3rd week, 6th week INCLUSION CRITERIA: 1. Clinical diagnosis of OSMF 2. Mouth opening between 20 30 mm (according to Lydner s classification group C) 3. No prior treatment for OSMF in the last 6 months