Efficacy of treatment modalities of oral submucous fibrosis at clinical and histopathological level-Comparing intralesional corticosteroids in combination with hyaluronidases therapy, soft LASER (ErCr:YSGG)fibrotomy and intralesional autologous platelet-rich-plasma - A Prospective Randomized Clinical Trial

Oral submucous fibrosis is the most common potentially malignant disorder of Indian subcontinent resulting in severe morbidity of trismus. In the present study four treatment modalities like intralesional Corticosteroids, Intralesional Hyaluronidase, Intralesional autologous Platelet-rich-plasma and LASER(Er-Cr-YSGG) fibrotomy have been selected to treat each group of patients randomly. This study is a Prospective Randomized Clinical four-arm Trail of the sample size 84 subjects. Each group has 21 subjects are intended to know the efficacy of the four treatment modalities clinically and histologically. Each subject of the three intralesional groups are treated weekly once for 6 weeks respectively. The LASER fibrotomy is undertaken in fourth group. Each subject of all the groups is followed at an interval of 3months, 6months,9months for the prognostic changes of clinical symptoms. The outcomes are subjected to statistical analysis using G*power. One way analysis of variance. Type1 - error of 5%, Effect size :0.8. Anticipated dropout rate 10%. Each variant of clinical symptoms is compared among the groups anticipating the hypothesis of intralesional autologous Platelet-rich-plasma is novel less invasive regenerative, remodeling treatment modalities and patient compliance in reducing morbid conditions like trismus.