Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A

• Status: Completed
• Trial end date: 2020-06-20
• Target enrollment: 0
• Participant gender: All

Summary

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, its dosage and injection sites effect among patients are controversial.The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage and injection sites. 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 single-point injection of 2 U BTX-A per side in the Simplified Method. And after 8 months, the Individualized Method was administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment. Data were collected at baseline and 4, 12, and 32 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