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Botox for Gummy Smile

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ClinicalTrials.gov Identifier: NCT03284047
Recruitment Status : Withdrawn (The study never started.)
First Posted : September 15, 2017
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief 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.


Condition or disease Intervention/treatment Phase
Gingival Exposure Drug: Botulinum toxin type A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile
Estimated Study Start Date : April 24, 2019
Estimated Primary Completion Date : April 24, 2019
Estimated Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: 2.5 U dose

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.

Experimental: 5 U dose

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.

Experimental: 7.5 U dose

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.




Primary Outcome Measures :
  1. Reduction of the upper gum exposure at 4 weeks and 12 weeks. [ Time Frame: [Baseline, 4 weeks,12 weeks] ]
    Reduction in millimeters in the upper gum exposure of subjects after botulinum toxin type A (abobotulinumtoxin A) treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284047


Locations
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United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University

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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT03284047     History of Changes
Other Study ID Numbers: STU00205065
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents