Botulinum Toxin A in the Management of a Gummy Smile: A Clinical Controlled Preliminary Study.

[BACKGROUND] Botulinum toxin type A (BTX-A) is recent technique for the treatment of gummy smile.

[OBJECTIVES] The aim of this randomized controlled preliminary clinical trial was to evaluate the effects of BTX-A on excessive gingiva display (EGD) reduction, muscle activity, and patient satisfaction at 2, 8, 12, 16, 21, and 25 weeks.

[METHODS] Group 1 (G1) received 4 points of BTX-A application (2 U/point) for relaxation of the levator labii superioris alaeque nasi and levator labii superioris muscles; Group 2 (G2) received 2 points of BTX-A (2 U/point) for relaxation of only the levator labii superioris alaeque nasi muscle.

[RESULTS] A high dropout of patients from follow-up sessions occurred. Therefore, because of this data limitation, the results were considered a preliminary outcome. At 2 weeks, there was a significant difference between baseline regarding the reduction of EGD in G1 and G2, reduction in muscle activity in G1, and increased satisfaction in G1 and G2. At 2 weeks, there was no difference between the 2 groups. Statistically significant EGD reduction was maintained until 16 weeks in G2 and 25 weeks in G1. After 14 days there was a gradual recovery of muscle activity in both groups until recovery of baseline values by 25 weeks. Patients' satisfaction with treatment lasted 21 weeks in G1 and 16 weeks in G2.

[CONCLUSIONS] Increasing the number of BTX-A injection points resulted in a prolonged effect regarding EGD reduction and patient satisfaction but did not increase the intensity of the outcome. However, due to the high dropout of patients, this is a preliminary conclusion and further studies are necessary to confirm these results.