Vasodilator isoxsuprine alleviates symptoms of oral submucous fibrosis

Objectives The aim of the study was to compare the effectiveness of vasodilator isoxsuprine to dexamethasone with hyaluronidase injections and physiotherapy in the treatment of oral submucous fibrosis. Materials and methods Forty patients with oral submucous fibrosis were randomly assigned into three groups. Group A patients ( n = 15) received 10 mg isoxsuprine tablets four times per day, group B ( n = 15) biweekly dexamethasone with hyaluronidase intralesional injections, and group C ( n = 10) placebo tablets. In addition, all patients were instructed physiotherapy exercises. The treatment time was 6 weeks and patients were followed-up for 4 months thereafter. The effect of the treatment was evaluated by measurements of inter-incisal distance and oral burning sensation and evaluation of histological findings of the diseased mucosa. Results Mouth opening increased and burning sensation decreased significantly in all groups, but the effects were significantly greater in groups receiving either oral isoxsuprine or dexamethasone with hyaluronidase injections in addition to physiotherapy. The decrease in burning sensation occurred more rapidly in patients receiving intralesional dexamethasone with hyaluronidase. Histological improvement was not observed in any of the groups. Conclusions Oral isoxsuprine as well as dexamethasone with hyaluronidase injections combined to physiotherapy alleviate symptoms of oral submucous fibrosis significantly more efficiently than physiotherapy alone. Clinical relevance Oral isoxsuprine can be considered as a new candidate drug for the treatment of oral submucous fibrosis. Physiotherapy exercises provide relief of symptoms and should be instructed to all patients.