Gingival ExposureNCT03284047
Botox for Gummy Smile
A study testing Botulinum toxin type A in people with Gingival Exposure, run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Exposure
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 24 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Subjects with neoplastic, muscular or neurological disease
- Subjects who have received botulinum toxin treatment for gummy smile in the previous 12 months before the inclusion date
- Subjects who have received Botulinum toxin treatment for any other cosmetic indication in the previous 6 months before the inclusion date
Show all 11Show fewer
- Subjects using aminoglycosides and penicillamine antibiotics, quinine or calcium channel blockers
- Subjects with inflammation or active infection in the area to be injected
- Subjects with history of sensitivity to the components of the formulation.
- Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- Subjects who are unable to understand the protocol or give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: 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).
Read more
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.
- Conditions
- Gingival Exposure
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ADrug
Participants will be randomized to one of three botulinum toxin type A doses.
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. 2.5 U
2. 5 U
3. 7.5 U Receives: Drug: Botulinum toxin type A |
| 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:
1. 2.5 U
2. 5 U
3. 7.5 U Receives: Drug: Botulinum toxin type A |
| 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:
1. 2.5 U
2. 5 U
3. 7.5 U Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Baseline, 4 weeks,12 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start24 Apr 2019 (estimated)
- Primary completion24 Apr 2019 (estimated)
- Study completion24 Apr 2019 (estimated)
Why it stopped: The study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival ExposureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284047
- Sponsor's protocol ID
- STU00205065
- Status last verified
- Dec 2021
- First submitted
- 13 Sep 2017
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Doses of Botulinum Toxin Type A for the Treatment of Gummy Smile
- ClinicalTrials.gov ID
- NCT03284047
- Acronym / sponsor ID
- STU00205065
- Conditions
- Gingival Exposure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (estimated)
- Primary completion
- 24 Apr 2019 (estimated)
- Study completion
- 24 Apr 2019 (estimated)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.5 U dose | Experimental | Drug: Botulinum toxin type AParticipants 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 |
| 5 U dose | Experimental | Drug: Botulinum toxin type AParticipants 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 |
| 7.5 U dose | Experimental | Drug: Botulinum toxin type AParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
- Subjects with neoplastic, muscular or neurological disease
- Subjects who have received botulinum toxin treatment for gummy smile in the previous 12 months before the inclusion date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AParticipants will be randomized to one of three botulinum toxin type A doses. | Drug | 2.5 U dose, 5 U dose, 7.5 U dose |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Gingival Exposure
RecruitingObservational study
SMOKING AND GINGIVAL CREVICULAR FLUID MFN1 AND NLRP3 LEVELS IN PERIODONTAL HEALTH AND PERIODONTITIS
Periodontitis, Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A in people with Gingival Exposure, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the upper gum exposure at 4 weeks and 12 weeks. (time frame: [Baseline, 4 weeks,12 weeks]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.