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.