drugset / Trial / NCT05127018

Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile

NCT05127018

Phase 1/2 Completed 33 enrolled Peking University
Non-randomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2019-11-20
Primary completion
2020-08-20
Completion
2021-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 2 iu
Subject Botulinum toxin type A Protein / enzyme biologic 3 iu
Subject Botulinum toxin type A Protein / enzyme biologic 5 iu
Subject Botulinum toxin type A Protein / enzyme biologic 10 iu

Indications

No indication recorded.