drugset / Trial / NCT04820543

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

NCT04820543 ↗

Phase 4 Completed 55 enrolled Peking University
Non-randomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2019-02-20
Primary completion
2019-11-20
Completion
2020-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum type A Unknown 2 iu Intramuscular
Subject Botulinum type A Unknown 3 iu Intramuscular
Subject Botulinum type A Unknown 5 iu Intramuscular