ABSTRACT
Oral Sub Mucous Fibrosis (OSMF) is a common condition found in India due to unique habit of chewing areca nut mixed with pan masala, gutkha, tobacco and spicy food etc. Once started and if neglected it can get transformed into malignancy. The disease once stared can only be controlled with life style changes. We wanted to study the effectiveness of intralesional injection of triamcinolone acetonide, oral llycopene alone and a combination of both in the treatment of oral submucous fibrosis. METHODSThis is a randomised comparative study. All cases with history of chewing of areca nut, pan masala, gutkha, tobacco and associated intolerance to spicy food, restricted mouth opening (grade III) and of age ranging between 15 - 70 years irrespective of gender were included in this study. Patients with previous history of treatment for oral sub mucus fibrosis, disorders of temporomandibular joint and pre-malignant conditions such as leukoplakia, drug allergy were excluded. A total of 150 enrolled cases were randomized into group I, II and III and treated with 1 mL of intralesional injection of triamcinolone acetonide weekly, lycopene capsule twice daily and both in combination respectively for a period of two months. Group II and III cases received oral lycopene throughout the study period, whereas group I and III cases received weekly injection of triamcinolone acetonide till mouth opening of 36 mm or more was achieved. All cases were followed up every two weeks for entire study period of two months, final follow up after two months and oral cavity was assessed for mucosal ulcerations, palpable fibrous bands, mouth opening in millimetres, and tolerance to spicy foods. RESULTSThe number of males and females amongst all groups was 71 and 79 respectively. The most common age group was 51 - 70 years. The mouth opening in 150 cases (grade III) of all groups showed significant improvement (p < 0.001) to grades I and II, of which the group III had maximum mouth opening of 20.22 ± 0.07mm. Amongst all groups in 143 cases, painful mucosal ulcerations disappeared in 136 (95.10 %) and majority (49) were from group II. Similarly, amongst all groups in 142 cases the symptom of burning sensation disappeared in 130 (91.5 %), and majority (49) were from group III. Also, amongst all groups in 150, palpable fibrous bands in oral cavity disappeared significantly in 138 (92 %) (p < 0.15), and the majority (49) were from group III, in remaining 12 it became supple. CONCLUSIONSGroup III agent lycopene in combination with triamcinolone acetonide was more effective than triamcinolone acetonide and lycopene of group I and II respectively when used singly in improving the symptoms and signs of OSMF.