Botox for Gummy Smile (NCT03284047) | Clinical Trial Compass
WithdrawnNot Applicable
Botox for Gummy Smile
Stopped: The study never started.
United States0Started 2019-04-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Males or females ≥ 18 years old
✓. Anterior gingival exposure during smiling larger than 4 mm measured from the central incisor tooth (part A), or 2-4 mm (part B).
✓. Subjects of childbearing potential who present a negative urine pregnancy test at baseline and use an effective contraceptive method.
✓. Subjects are in good health as judged by the investigator.
✓. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion criteria
✕. Pregnant women or women intending to become pregnant in the next 8 months after the screening for eligibility
✕. Subjects participating in other clinical trials
✕. Any prior surgery affecting the area of study
What they're measuring
1
Reduction of the upper gum exposure at 4 weeks and 12 weeks.