Efficacy of Combination of Intralesional Pentoxifylline and Dexamethasone with Intralesional Pentoxifylline, Intralesional Dexamethasone alone in the Treatment of Oral Submucous Fibrosis- A Pilot Study.

Background: Oral submucous fibrosis (OSMF) is a debilitating oral disease, causing progressive loss of vascularity in the diseased mucosa, resulting in epithelial atrophy. Therefore, this pilot study aimed to use intralesional pentoxifylline to increase blood supply to the local tissues, helping in eliminating or reducing the severity of OSMF.

Aims and objectives: To comparatively evaluate the effectiveness of the combination of intralesional pentoxifylline and dexamethasone with pentoxifylline and dexamethasone alone in assessing the mouth opening, burning sensation, and USG parameters. The USG parameters included submucosal thickness, echoicity, and blood vascularity. The pilot study results were compared among the three study groups, in terms of increase in mouth opening, reduction in burning sensation, and the above-mentioned USG parameters.

Methods: Patients were categorized randomly into Group I (n = 05), Group II (n = 05), and Group III (n = 05): Group I, intralesional dexamethasone 4 mg/ml, Group II, Intralesional PTX 1 mg/ml, while in Group III, combination of both drugs was administered, biweekly for 3 months along with active physiotherapy. Ultrasonography and colour Doppler were done pre- and post-treatment.

Results: The increase in mouth opening in Group III was 115%, and in Group II that was 63.46% as compared to Group I 19.28% after 26th dose. The results of various parameters considered in this study were overall better in combination group as compared to other two groups.

Conclusion: This regimen will improve quality of life, function, and patient compliance along with down staging of Grade of OSMF.Trial registration number: CTRI/ 2020/09/027836.