Effectiveness of Mouth Opening Device (MOD) as an adjunct to intralesional corticosteroid injection in the management of Oral Submucous Fibrosis – A Single-Blinded Randomized Clinical Trial

Designing and Manufacturing of Mouth Opening Device:

The device is autoclavable, made of high-quality, rust-free stainless steel, and features a knurled screw head for smooth vertical opening up to a maximum of 45mm. It consists of upper and lower horizontal plates that fit the upper and lower arches, accommodating dentulous and edentulous patients. With a screw thread mechanism, the mouth opening can be easily increased, and the calibration on the vertical arm and arrow on the lower plate allows for easy measurement. This device is easy to use, portable, and enhances the patient’s quality of life.

Methodology:

Patients will be selected based on inclusion and exclusion criteria from the Outpatient Department of Oral Medicine and Radiology at KLE VK Institute of Dental Sciences, Belagavi, Karnataka.

Details of the procedure to be conducted during the study

The study will begin with participant recruitment and screening from the Outpatient Department of Oral Medicine and Radiology, where potential participants will be approached, informed about the study objectives and procedures in their local language, and screened according to inclusion and exclusion criteria. Eligible participants will provide written informed consent before proceeding. On the baseline assessment day (Week 0), demographic details and habit history will be recorded, followed by clinical staging of Oral Submucous Fibrosis (OSMF) as per established criteria. Interincisal mouth opening will be measured using a calibrated Vernier caliper, burning sensation will be recorded using a Visual Analogue Scale (VAS) ranging from 0–10, and the Oral Health Impact Profile-14 (OHIP-14) questionnaire will be administered to assess quality of life. Participants will then be randomized into two groups using the chit-picking method. Group I (Control) will receive weekly intralesional injections of Dexamethasone 4 mg with Hyaluronidase 1500 IU (1 ml per side) into the bilateral buccal mucosa for six consecutive weeks. Group II (Intervention) will receive the same injections along with a Mouth Opening Device (MOD), for which usage will be demonstrated and scheduled at three sessions per day, 15 minutes per session, with instructions to gradually increase pressure as tolerated; patients in this group will also maintain a daily usage logbook for compliance monitoring. Follow-up visits will be conducted at Week 3 and Week 6 to reassess interincisal distance, VAS score, and—at Week 6—the OHIP-14 questionnaire, along with recording any adverse effects. Post-treatment evaluation at Week 6 will include final measurements of mouth opening, burning sensation, and OHIP-14 scores, along with compliance assessment for MOD usage in the intervention group, followed by data entry and verification.