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SmilingPhase 4NCT04820543

Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A

A Phase 4 study testing injection of Botulinum type A in people with Smiling and Botulinum Toxins, Type A, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, its dosage and injection sites effect among patients are controversial.The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage and injection sites. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Smiling, Botulinum Toxins, Type A
What is being tested?
injection of Botulinum type A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
20 Feb 2019to 20 Jun 2020
Phase
Phase 4
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ≥ 3.0-mm anterior gingival exposure upon unrestricted, "full-blown" smiling
  • healthy adults

Who cannot join

  • contraindication of BTX-A
  • previous diseases or treatments affecting the position of the gingiva or upper lips
  • history of BTX-A injections to the head or neck region
  • facial paralysis
  • having received and/or receiving active orthodontic treatment that includes vertical dimension treatment, such as extrusion and intrusion, and presence of periodontal disease
  • subject's refusal to participate

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University School and Hospital of Stomatology

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A: A Prospective Study

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, its dosage and injection sites effect among patients are controversial.The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage and injection sites. In this prospective self-controlled study, healthy GS participates who had an anterior gingival exposure (GE) of more than 3 mm were enrolled and administered single-point injection of 2 U BTX-A per side in the Simplified Method. And after 8 months, the Individualized Method was administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment. Data were collected at baseline and 4, 12, and 32 weeks of follow-up.

Read the detailed description

The smile is one of universal facial expressions of the humans. Gingival smile (GS) or gummy smile defined as any exposure of the gingiva >2 or 3 mm upon smiling, and can substantially vary from patient to patient, with patients presenting gummy exposures of up to more than 10 mm. The prevalence of GS is 10.57%, and it is more frequently seen in women. Although only an anatomical variation, it can be considered unattractive and cause significant distress and impact on one's quality of life. Moreover, most orthodontists and dentists regard GS as an important risk factors for dental treatment.

GS involves a complex interaction of facial muscles, bones and skin, specifically, it is related to the hypermobile upper lip (HUL) by the involved muscles and alterations in anatomical features such as short clinical dental crown, anterior dentoalveolar extrusion, maxillary excess and short upper lip. Therapies for GS range from botulinum toxin injections to surgical interventions according to its etiology. Whereas the outcomes of surgical procedures are long-lasting, botulinum toxin type A (BTX-A) treatment is an easy and fast outpatient procedure, requiring no downtime and with high efficacy rates. Nevertheless, there are controversies on the dosage and injection sites of BTX-A, and the efficiency of BTX-A for GS treatment shows great variation in different studies, with the improvement rate of gingival exposure (GE) ranging from 62.06% to 98%, Sucupira and Abramovitz advocate the use of an average amount of BTX-A of 2 U at bilateral levator labii superioris alaeque nasi muscles(LLSAN) for the treatment of GS, and an average satisfaction level of 9.75 on a 10-point scale was noted in their study. In their article, use of larger dosages and additional injection sites is discouraged: "Other target muscles described in the literature do not give any additional benefit to this application and could easily lead to lip ptosis, inferior lip protrusion, asymmetry, or excessive lengthening of the upper lip." Polo disagreed their argument. They believe that dosage and injection sites of BTX-A need to be individualized according to the degree of severity presented. However, no clinical study compared and verified their divergence, and the highly personal experience and uncertainty still limit the use of BTX-A for GS treatment. Some authors are of the opinion that injection with BTX-A is a safe and cosmetically effective treatment for GS only when performed by experienced practitioners. Other studies preferred to initiate the treatment with average-dose BTX-A injection to single sites initially, with retouching at a later stage, as and when required. Based on the lack of studies at the stage of creating the hypothesis for this study, the investigators compared the efficiency using the simplified method use of 2U BTX-A of at bilateral LLSAN and the individualized injection of dosage and injection sites according to the severity of anterior GS presented in patients, and also to assess safety and patients' satisfaction with the treatment.

Being tested
injection of Botulinum type A
Keywords
gummy smile, botulinum toxin, dose and injection site
Medical subject headings
Smiling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • injection of Botulinum type ADrug

    Also called injection of Botulinum type A(Botox, Allergan, Irvine, CA)

    The participates were allocated to two different application methods: Simplified Method for the first injection and Individualized Method 8 months later. All the patients underwent twice injection with each methods with no change of the BTX-A(Botox, Allergan, Irvine, CA) and other injection details: Lyophilized 100 U of Botox was reconstituted in 2.5 mL of 0.9% sodium chloride solution. The injections were made with a 27-gauge insulin syringe. The treatment was an outpatient procedure and all injections were performed by one of the authors (X.G.). No anesthesia was given during the procedure.

Study groups in NCT04820543
Study groupRoleWhat they receive
Simplified MethodExperimentalIn this method, a uniform BTX-A injection technique with single-site injection of 2 U BTX-A (total, 4 U) at both right and left levator labii superioris alaeque nasi muscles (LLSAN) was administered. The injection points located at the muscle bulge at the uppermost part of the nasolabial fold.
Receives: Drug: injection of Botulinum type A
Individualized MethodExperimentalIn this method, the patients were administered BTX-A after 8 months when the effect of the previous injection vanished. And A dosage and injection sites were individualized according to the degree of severity of anterior GE presented pretreatment. For mild GS (3 to< 5mm), 2 U BTX-A was injected at bilateral LLSAN. For moderate (5 to < 7mm) and severe GS (≥ 7mm), 3 U and 5 U of BTX-A were injected per side (total, 6 U and 10U). And The injection points located at both LLSAN and the Yonsei point, with half doses at each point.
Receives: Drug: injection of Botulinum type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. anterior gingival exposure (GE)

    The distance from the superior margin point of the right incisor to the lower margin of the upper lip upon maximum smile.

    Measured: 4 weeks postinjection

Secondary outcomes (1)
  1. bilateral posterior GE

    The distance between the superior margin point of the right first premolars, the left first premolars and the lower margin of the upper lip, respectively.

    Measured: 4 weeks postinjection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start20 Feb 2019
  3. Primary completion20 Nov 2019
  4. Study completion20 Jun 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04820543
Sponsor's protocol ID
pkussGS2
Status last verified
Mar 2021
First submitted
24 Mar 2021
Last updated
1 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators did not have the plan to make individual participant data available to other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing injection of Botulinum type A in people with Smiling and Botulinum Toxins, Type A, run by Peking University at 1 site in China.

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 2 inclusion and 6 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: finished, as of the sponsor's last update on 1 Apr 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 China. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

anterior gingival exposure (GE) (time frame: 4 weeks postinjection). 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 1 Apr 2021.

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