drugset / Trial / NCT03284047

Botox for Gummy Smile

NCT03284047

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a two part study to measure and observe the efficacy of botulinum toxin A for the treatment of gummy smiles. Part A will randomly compare three different doses of botulinum toxin type A (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival exposure (\> 4 mm). Part B will assign one of two doses of botulinum toxin type A for participants with smaller gingival exposure (\< 4 mm). Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. This study is a pilot study designed to determine feasibility of this procedure.

Timeline

Start
2019-04-24
Primary completion
2019-04-24
Completion
2019-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 2.5 iu
Subject Botulinum toxin type A Protein / enzyme biologic 5 iu
Subject Botulinum toxin type A Protein / enzyme biologic 7.5 iu

Indications