An interventional study of Botulinum toxin type A in Gingival Exposure, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows: 1. 2.5 U 2. 5 U 3. 7.5 U
Drug: Botulinum toxin type A
Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows: 1. 2.5 U 2. 5 U 3. 7.5 U
Drug: Botulinum toxin type A
Participants with more than 4 mm of upper anterior gingival exposure measured from the central incisor tooth will be randomly assigned (1:1:1) to receive different doses of botulinum toxin type A (abobotulinumtoxin A) on the levator labii superioris alaeque nasi as follows: 1. 2.5 U 2. 5 U 3. 7.5 U
Drug: Botulinum toxin type A
Participants will be randomized to one of three botulinum toxin type A doses.
Reduction of the upper gum exposure at 4 weeks and 12 weeks.
Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.
Time frame: [Baseline, 4 weeks,12 weeks]
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Northwestern University