Botox for Gummy Smile



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:April 1, 2019
End Date:December 30, 2020
Contact:Emily Poon, PhD
Email:nufsm-dermatology@northwestern.edu
Phone:312-695-4761

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Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile

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.


Inclusion Criteria:

1. Written informed consent

2. Males or females ≥ 18 years old

3. Anterior gingival exposure during smiling larger than 4 mm measured from the central
incisor tooth (part A), or 2-4 mm (part B).

4. Subjects of childbearing potential who present a negative urine pregnancy test at
baseline and use an effective contraceptive method.

5. Subjects are in good health as judged by the investigator.

6. 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:

1. Pregnant women or women intending to become pregnant in the next 8 months after the
screening for eligibility

2. Subjects participating in other clinical trials

3. Any prior surgery affecting the area of study

4. Subjects with neoplastic, muscular or neurological disease

5. Subjects who have received botulinum toxin treatment for gummy smile in the previous
12 months before the inclusion date

6. Subjects who have received Botulinum toxin treatment for any other cosmetic indication
in the previous 6 months before the inclusion date

7. Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium
channel blockers

8. Subjects with inflammation or active infection in the area to be injected

9. Subjects with history of sensitivity to the components of the formulation.

10. Uncooperative patients or patients with neurological disorders who are incapable of
following directions or who are predictably unwilling to return for follow-up
examinations.

11. Subjects who are unable to understand the protocol or give informed consent.
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Murad Alam, MD
Phone: 312-695-4761
?
mi
from
Chicago, IL
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