Preoperative intramuscular botulinum Toxin-A to enhance postoperative outcomes in oral submucous fibrosis surgery: A randomized controlled trial.

[UNLABELLED] The aim of this Randomized Controlled Trial (RCT) was to evaluate the pain relief and mouth opening achieved with preoperative injection of Botulinum Toxin-A (BTX-A) into bilateral temporalis and masseter muscles in patients with Oral Submucous Fibrosis (OSMF), following surgical intervention, compared to the control group. Additionally, the effectiveness of BTX-A in the uptake of the Buccal Fat Pad (BFP) graft and the patient satisfaction score were also studied.

[MATERIAL AND METHODS] Twenty patients with OSMF were randomly assigned to two groups (n = 10 each). Group A received BTX-A injections preoperatively, while Group B received normal Saline (NS) injections, which were followed by surgical intervention. All patients underwent fibrotomy followed by reconstruction using a Buccal Fat Pad (BFP) graft. The outcomes assessed were pain and mouth opening at 1 week, and at 1, 3, and 6 months postoperatively. Graft uptake and patient satisfaction were evaluated at the 3rd and 6th months, respectively. Pain was assessed using the Numeric Rating Scale (NRS), mouth Opening was measured using a stainless-steel ruler, graft uptake was evaluated clinically, and patient satisfaction score was recorded using a Likert Scale.

[RESULTS] A statistically significant reduction in mean pain score was seen at 1, 3, and 6 months postoperatively in the BTX-A group. Although an increased mouth opening was noted in the BTX-A group, the difference between the two groups was not statistically significant. There was a statistically significant difference between the mean patient satisfaction score of the BTX-A and NS groups at 6 months, in favour of the BTX-A group. Graft uptake was uneventful in both groups.

[CONCLUSION] BTX-A appears to be a valuable adjunct to surgery and physiotherapy in the management of OSMF by enhancing postoperative comfort and outcomes.