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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5 U dose | Experimental | 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:
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| 5 U dose | Experimental | 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:
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| 7.5 U dose | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Participants will be randomized to one of three botulinum toxin type A doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | [Baseline, 4 weeks,12 weeks] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |