CClinicalTrials.gg
WithdrawnNCT03284047Updated Dec 6, 2021

Botox for Gummy Smile

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 Withdrawn at 1 site in United States.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

Why this study was withdrawn
The study never started.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gingival Exposure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugBotulinum toxin type A

    Participants will be randomized to one of three botulinum toxin type A doses.

05

What researchers measure

Primary outcomes

  1. 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]

06

Study locations

1 site
  • Northwestern University Department of Dermatology
    Chicago, Illinois 60611, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03284047
Lead sponsor
Northwestern University
Responsible party
Murad Alam (Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University) — Principal investigator
First posted
Sep 15, 2017
Start date
Apr 24, 2019 (estimated)
Primary completion
Apr 24, 2019 (estimated)
Completion
Apr 24, 2019 (estimated)
Last update
Dec 6, 2021

Study contacts

Murad Alam, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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