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SmilingPhase 2NCT03812965

Botulinum Toxin in the Treatment of Gingival Smile

A Phase 2 study testing Botulinum toxin type A in people with Smiling, run by Universidade Ibirapuera at 1 site in Brazil.

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

Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum toxin. Materials and methods: The randomized, double-blind clinical trial (patient and examiner) will be conducted by two trained and calibrated dentists. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Smiling
What is being tested?
Botulinum toxin type A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
1 Aug 2018to 8 Apr 2019
Phase
Phase 2
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients of both genders exhibiting gingival exposure greater than or equal to 3 mm above the central incisor during smile
  • Patients with good general health and good oral hygiene.

Who cannot join

  • Patients with Botulinum Toxin allergy or albumin, or who have previously performed botulinum toxin facial treatment previously.
  • Patients with Amyotrophic Lateral Sclerosis, Neuropathy, Myasthenia Gravis or Lambert-Eaton Syndrome, women who are pregnant or planning to become pregnant, are breastfeeding women.
  • Patients who are participating in other research involving other drugs.
  • Patients who use drugs that interfere with neuromuscular transmission

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Ibirapuera

    São Paulo, São Paulo, 04661-100

Other trials in Brazil

About this study

Official title: Effectiveness and Durability of Botulinum Toxin Application in the Treatment of Gingival Smile

Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum toxin. Materials and methods: The randomized, double-blind clinical trial (patient and examiner) will be conducted by two trained and calibrated dentists. Ten patients will be randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift® (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2 units/point was injected in the muscles: levators labii superioris alaeque nasi muscle, totalizing 2 points. The amount of exposed gingiva during smile will be measured using a pachymeter and the muscle activity of the region will be evaluated through electromyography, before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort due to treatment will be evaluated in the same periods through questionnaire. The impact of the treatment in life quality will be evaluated through OHIP-14 questionnaire.

Conditions
Smiling
Keywords
Botulinum Toxin, Gingival Smile
Medical subject headings
Smiling

What participants receive

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

Study groups in NCT03812965
Study groupRoleWhat they receive
Group 1 - Botulinum Toxin type A (4 points of application)Experimental4 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle (n=10 Patients)
Receives: Drug: Botulinum toxin type A
Group 2 - - Botulinum Toxin type A (2 points of application)Experimental2 points of Botulinum Toxin application in the muscles: Levators labii superioris alaeque nasi muscle (n=10 Patients)
Receives: Drug: Botulinum toxin type A

What is being measured

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

  1. Exposed Gingiva during Smile (mm)

    Measurement of exposed gingiva during smile using a pachymeter

    Measured: Before Treatment

  2. Exposed Gingiva during Smile (mm)

    Measurement of exposed gingiva during smile using a pachymeter

    Measured: After Treatment (2 weeks)

  3. Exposed Gingiva during Smile (mm)

    Measurement of exposed gingiva during smile using a pachymeter

    Measured: After Treatment (8 weeks)

  4. Exposed Gingiva during Smile (mm)

    Measurement of exposed gingiva during smile using a pachymeter

    Measured: After Treatment (12 weeks)

  5. Exposed Gingiva during Smile (mm)

    Measurement of exposed gingiva during smile using a pachymeter

    Measured: After Treatment (21 weeks)

  6. Exposed Gingiva during Smile (mm)

    Measurement of exposed gingiva during smile using a pachymeter

    Measured: After Treatment (25 weeks)

Secondary outcomes (6)

  1. Muscles Activity

    Muscles activity using electromyography

    Measured: Before Treatment

  2. Muscles Activity

    Muscles activity using electromyography

    Measured: After Treatment (2 weeks)

  3. Muscles Activity

    Muscles activity using electromyography

    Measured: After Treatment (8 weeks)

  4. Muscles Activity

    Muscles activity using electromyography

    Measured: After Treatment (12 weeks)

  5. Muscles Activity

    Muscles activity using electromyography

    Measured: After Treatment (21 weeks)

  6. Muscles Activity

    Muscles activity using electromyography

    Measured: After Treatment (25 weeks)

Timeline

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

  1. First posted23 Jan 2019
  2. Study start1 Aug 2018
  3. Primary completion8 Feb 2019
  4. Study completion8 Apr 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812965
Sponsor's protocol ID
80103617.0.0000.5597
Status last verified
Jun 2019
First submitted
17 Jan 2019
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botulinum toxin type A in people with Smiling, run by Universidade Ibirapuera at 1 site in Brazil.

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 4 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 5 Jun 2019. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Exposed Gingiva during Smile (mm) (time frame: Before Treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03812965.

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 5 Jun 2019.

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