Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile

• Status: Completed
• Trial end date: 2021-10-20
• Target enrollment: 0
• Participant gender: All

Summary

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, the necessary for higher-doses among patients are controversial. The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage. In this prospective self-controlled study, healthy GS participates who had an anterior gingival exposure (GE) of more than 3 mm were enrolled and administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment in the Average-dose Method. And after 8 months, the Higher-doses Method was administered the same point injection of 3-10 U BTX-A (total, 6-20 U). Data were collected at baseline and 4, 12, 32 and 60 weeks of follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peking University

Criteria

Inclusion Criteria:

• ≥ 3.0-mm anterior gingival exposure upon unrestricted, "full-blown" smiling

• healthy adults

Exclusion Criteria:

• contraindication of BTX-A

• previous diseases or treatments affecting the position of the gingiva or upper lips

• history of BTX-A injections to the head or neck region

• facial paralysis

• having received and/or receiving active orthodontic treatment that includes vertical dimension treatment, such as extrusion and intrusion, and presence of

• periodontal disease

• subject's refusal to participate